Class II U.S. Food and Drug Administration

B Braun Medical Inc IV Administration Set utilized in gravity IV administration sets recall: Potential for backflow of medication from secondary (piggyback) IV containers

Recall published 11 months ago

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0670-2026
Published
December 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
B Braun Medical Inc
Product type
Medical devices
Units affected
20,694,734 units
Made in
United States
Lot / code info
1. Catalog Number: 352636; Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date. 2. Catalog Number: 352639; Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date. 3. Catalog Number: 352640; Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date. 4. Catalog Number: 352643; Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date. 5. Catalog Number: 477003; Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths. 6. Catalog Number: 477006; Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths. 7. Catalog Number: 477008; Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths. 8. Catalog Number: 477012; Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths. 9. Catalog Number: 477019; Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths. 10. Catalog Number: 477021; Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths. 11. Catalog Number: 477022; Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths. 12. Catalog Number: 477023; Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths. 13. Catalog Number: 477053; Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths. 14. Catalog Number: 490513; Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths. 15. Catalog Number: 490521; Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths. 16. Catalog Number: 490527; Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths. 17. Catalog Number: 490529; Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths. 18. Catalog Number: 490535; Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths. 19. Catalog Number: 490543; Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths. 20. Catalog Number: 490546; Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths. 21. Catalog Number: 490547; Primary UDI-DI: 04046955270286; Unit of Dose UDI-DI: 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths. 22. Catalog Number: 490552; Primary UDI-DI: 04046955275342; Unit of Dose UDI-DI: 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths. 23. Catalog Number: 490553; Primary UDI-DI: 04046955275366; Unit of Dose UDI-DI: 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths. 24. Catalog Number: 490554; Primary UDI-DI: 04046955275380; Unit of Dose UDI-DI: 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths. 25. Catalog Number: 490555; Primary UDI-DI: 04046955275403; Unit of Dose UDI-DI: 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths. 26. Catalog Number: 490558; Primary UDI-DI: 04046955275465; Unit of Dose UDI-DI: 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths. 27. Catalog Number: 490559; Primary UDI-DI: 04046955275489; Unit of Dose UDI-DI: 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths. 28. Catalog Number: 490560; Primary UDI-DI: 04046955275502; Unit of Dose UDI-DI: 04046955275496; E…
UPC codes
04046955594597, 04046955594580, 04046955594672, 04046955594665, 04046955594696, 04046955594689, 04046955594757, 04046955594740, 04046955202836, 04046955202829, 04046955202751, 04046955202744, 04046955202850, 04046955202843, 04046955202874, 04046955202867, 04046955203147, 04046955203130, 04046955269983, 04046955269976

Products covered by this recall

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DR W/2 SAFEDAY; Catalog Number: 352636. 2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639. 3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640. 4. IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643. 5. IV ADMIN SET, 105 IN.; Catalog Number: 477003. 6. IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006. 7. IV ADMIN SET, 121 IN.; Catalog Number: 477008. 8. IV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012. 9. IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019. 10. IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021. 11. IV ADMIN SET 114 IN.; Catalog Number: 477022. 12. IV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023. 13. IV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053. 14. IV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513. 15. IV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521. 16. IV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527. 17. IV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529. 18. IV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535. 19. IV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543. 20. IV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546. 21. IV ADMIN SET, 125 IN.; Catalog Number: 490547. 22. IV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552. 23. IV ADMIN SET, 120IN.; Catalog Number: 490553. 24. IV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554. 25. IV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555. 26. IV ADMIN SET 15D w/B/C VLV, 139 IN.; Catalog Number: 490558. 27. IV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559. 28. IV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560. 29. IV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561. 30. IV ADMIN SET 15D w/B/C VLV, 140 IN.; Catalog Number: 490562. 31. IV ADMIN SET, 111 IN.; Catalog Number: 490563. 32. IV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569. 33. IV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573. 34. IV ADMIN SET 15D w/B/C VLV, 110 IN.; Catalog Number: 490574. 35. IV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575. 36. IV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578. 37. IV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581. 38. IV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582. 39. IV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583. 40. IV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588. 41. IV ADMIN SET, 132 IN.; Catalog Number: 490589. 42. IV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600. 43. IV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607. 44. IV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Catalog Number: 490608. 45. IV ADMIN SET 15D 2 CARESITE LADS, 138 IN; Catalog Number: 490615. 46. IV SET 15DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490618. 47. IV SET 60DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490619. 48. IV ADMIN SET 15 DRPS 4W STOPCOCK W/ C&S; Catalog Number: 490644. 49. IV ADMIN SET 15 DRPS ULTRAP. ZERO 90.6IN; Catalog Number: 490657. 50. IV ADMIN SET 15 DRPS STOPCOCK MALE 117IN; Catalog Number: 490658.

Check your product

The notice names 60 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04046955594597
  • 04046955594580
  • 04046955594672
  • 04046955594665
  • 04046955594696
  • 04046955594689
  • 04046955594757
  • 04046955594740
  • 04046955202836
  • 04046955202829
  • 04046955202751
  • 04046955202744
  • 04046955202850
  • 04046955202843
  • 04046955202874
  • 04046955202867
  • 04046955203147
  • 04046955203130
  • 04046955269983
  • 04046955269976

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 36mths. 6. Catalo
  • 36mths. 7. Catalo
  • 36mths. 8. Catalo
  • 36mths. 9. Catalo
  • 36mths. 10. Catal
  • 36mths. 11. Catal
  • 36mths. 12. Catal
  • 36mths. 13. Catal
  • 36mths. 14. Catal
  • 36mths. 15. Catal
  • 24mths. 16. Catal
  • 36mths. 17. Catal
  • 24mths. 18. Catal
  • 36mths. 19. Catal
  • 36mths. 20. Catal
  • 36mths. 21. Catal
  • 36mths. 22. Catal
  • 36mths. 23. Catal
  • 36mths. 24. Catal
  • 36mths. 25. Catal

Model or item number

On the rating label, the box or the instruction sheet.

  • 2 SAFEDAY
  • 2 SAFEDAY 84
  • 3 SAFEDAY
  • 105
  • 4 CARESTIE LAD
  • 145
  • 121
  • CARESTIE LAD
  • 90
  • 2 CARESTIE LAD
  • 15D
  • 117IN
  • 5CARESITE LAD
  • 136 I
  • 126
  • 106
  • 15DR
  • CARESITE LAD
  • 121 I
  • 120

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

B Braun Medical Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: B Braun Medical Inc — 824 12th Ave, Bethlehem, PA, 18018-3524

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was B Braun Medical Inc medical devices recalled?

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04046955594597, 04046955594580, 04046955594672; best-by date 36mths. 6. Catalo or 36mths. 7. Catalo; model number 2 SAFEDAY, 2 SAFEDAY 84, 3 SAFEDAY. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

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