Infusomat utilized in gravity IV administration sets recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1. Catalog Number: 362032; Primary UDI-DI: 04046964182556; Unit of Dose UDI-DI: 04046964182549. Shelf Life: Earliest Exp of Comp or 60mths. 2. Catalog Number: 362033; Primary UDI-DI: 04046964837821; Unit of Dose UDI-DI: 04046964837814. Shelf Life: Earliest Exp of Comp or 36mths. 3. Catalog Number: 362034; Primary UDI-DI: 04046964182570; Unit of Dose UDI-DI: 04046964182563. Shelf Life: Earliest Exp of Comp or 48mths. 4. Catalog Number: 362043; Primary UDI-DI: 04046964182631; Unit of Dose UDI-DI: 04046964182624. Shelf Life: Earliest Exp of Comp or 60mths. 5. Catalog Number: 362050; Primary UDI-DI: 04046964182655; Unit of Dose UDI-DI: 04046964182648. Shelf Life: Earliest Exp of Comp or 60mths. 6. Catalog Number: 362420; Primary UDI-DI: 04046955592715; Unit of Dose UDI-DI: 04046955592708. Shelf Life: 36mths from Start Date. 7. Catalog Number: 362431; Primary UDI-DI: 04046964294013; Unit of Dose UDI-DI: 04046964294006. Shelf Life: Earliest Exp of Comp or 60mths. 8. Catalog Number: 362432; Primary UDI-DI: 04046964182679; Unit of Dose UDI-DI: 04046964182662. Shelf Life: Earliest Exp of Comp or 60mths. 9. Catalog Number: 363010; Primary UDI-DI: 04046964294174; Unit of Dose UDI-DI: 04046964294167. Shelf Life: Earliest Exp of Comp or 48mths. 10. Catalog Number: 363019; Primary UDI-DI: 04046964294198; Unit of Dose UDI-DI: 04046964294181. Shelf Life: Earliest Exp of Comp or 60mths. 11. Catalog Number: 363030; Primary UDI-DI: 04046964294259; Unit of Dose UDI-DI: 04046964294242. Shelf Life: Earliest Exp of Comp or 60mths. 12. Catalog Number: 363230; Primary UDI-DI: 04046964294495; Unit of Dose UDI-DI: 04046964294488. Shelf Life: Earliest Exp of Comp or 60mths. 13. Catalog Number: 363419; Primary UDI-DI: 04046964294570; Unit of Dose UDI-DI: 04046964294563. Shelf Life: Earliest Exp of Comp or 36mths. 14. Catalog Number: 363420; Primary UDI-DI: 04046964294594; Unit of Dose UDI-DI: 04046964294587. Shelf Life: Earliest Exp of Comp or 36mths. 15. Catalog Number: 363421; Primary UDI-DI: 04046964294617; Unit of Dose UDI-DI: 04046964294600. Shelf Life: Earliest Exp of Comp or 36mths. 16. Catalog Number: 363422; Primary UDI-DI: 04046964294631; Unit of Dose UDI-DI: 04046964294624. Shelf Life: Earliest Exp of Comp or 36mths. 17. Catalog Number: 363423; Primary UDI-DI: 04046964294655; Unit of Dose UDI-DI: 04046964294648. Shelf Life: Earliest Exp of Comp or 36mths. 18. Catalog Number: 363424; Primary UDI-DI: 04046964837906; Unit of Dose UDI-DI: 04046964837890. Shelf Life: Earliest Exp of Comp or 36mths. 19. Catalog Number: 363430; Primary UDI-DI: 04046964294679; Unit of Dose UDI-DI: 04046964294662. Shelf Life: 36mths from Start Date. 20. Catalog Number: 363433; Primary UDI-DI: 04046964837920; Unit of Dose UDI-DI: 04046964837913. Shelf Life: Earliest Exp of Comp or 36mths. 21. Catalog Number: 480254; Primary UDI-DI: 04046955324798; Unit of Dose UDI-DI: 04046955343904. Shelf Life: Earliest Exp of Comp or 36mths. 22. Catalog Number: 480255; Primary UDI-DI: 04046955324804; Unit of Dose UDI-DI: 04046955585403. Shelf Life: Earliest Exp of Comp or 36mths. 23. Catalog Number: 480256; Primary UDI-DI: 04046955324811; Unit of Dose UDI-DI: 04046955585861. Shelf Life: Earliest Exp of Comp or 36mths. 24. Catalog Number: 480258; Primary UDI-DI: 04046955324835; Unit of Dose UDI-DI: 04046955585885. Shelf Life: Earliest Exp of Comp or 36mths. 25. Catalog Number: 480263; Primary UDI-DI: 04046955693931; Unit of Dose UDI-DI: 04046955693924. Shelf Life: Earliest Exp of Comp or 36mths. 26. Catalog Number: 490100; Primary UDI-DI: 04046964186080; Unit of Dose UDI-DI: 04046964186073. Shelf Life: 36mths from Start Date. 27. Catalog Number: 490101; Primary UDI-DI: 04046964186103; Unit of Dose UDI-DI: 04046964186097. Shelf Life: Earliest Exp of Comp or 36mths. 28. Catalog Number: 490102; Primary UDI-DI: 04046964186127; Unit of Dose UDI-DI: 04046964186110. Shelf Life: Earliest Exp of Comp or 36mths. 29. Catalog Number: 490103; Primary UDI-DI: 04046964302107; Unit of Dose UDI-DI: 04046964302091. Shelf Life: Earliest Exp of Comp or 36mths. 30. Catalog Number: 490104; Primary UDI-DI: 04046964186141; Unit of Dose UDI-DI: 04046964186134. Shelf Life: Earliest Exp of Comp or 36mths. 31. Catalog Number: 490105; Primary UDI-DI: 04046964186165; Unit of Dose UDI-DI: 04046964186158. Shelf Life: Earliest Exp of Comp or 36mths. 32. Catalog Number: 490655; Primary UDI-DI: 04046955836383; Unit of Dose UDI-DI: 04046955836376. Shelf Life: Earliest Exp of Comp or 36mths.

Product

Infusomat 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 numbers: 1. UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 362032. 2. UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; Catalog Number: 362033. 3. 60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine; Catalog Number: 362034. 4. Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine¿; Catalog Number: 362043. 5. UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; Catalog Number: 362050. 6. SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY; Catalog Number: 362420. 7. UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, priming volume: 21mL, length: 120in, ULTRASITE; Catalog Number: 362431. 8. SPACE PUMP IV SET, 120 IN.; 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; Catalog Number: 362432. 9. 60 DROP METRISET PUMP SET,3 SFLINE ASV; Priming volume: 21mL, length: 121in, SafeLine; Catalog Number: 363010. 10. Y-TYPE BLOOD PUMP SET, SAFELINE, ASV; Priming volume: 40mL, length: 123in, SafeLine; Catalog Number: 363019. 11. UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 363030. 12. UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV; 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; Catalog Number: 363230. 13. Y-TYPE BLOOD PUMP SET, CARESITE, ASV; Priming volume: 41mL, length: 120in, CARESITE; Catalog Number: 363419. 14. SPACE PUMP IV SET, 2 CARESITES, ASV; 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; Catalog Number: 363420. 15. UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 363421. 16. 60DROP METRISET PUMP, 3 CARESITES, ASV; Priming volume: 21mL, length: 130in, CARESITE; Catalog Number: 363422. 17. UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV; 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; Catalog Number: 363423. 18. UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; Catalog Number: 363424. 19. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; Catalog Number: 363430. 20. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; Catalog Number: 363433. 21. SPACE PUMP IV SET 15D, 110 IN.; "SPACE PUMP IV SET 15D, 110 IN. CLOSE"; Catalog Number: 480254. 22. SPACE PUMP IV SET, 127 IN.; SPACE PUMP IV SET, 127 IN.; Catalog Number: 480255. 23. SPACE PUMP SET 15D, CARESITE LAD 122 IN. ; 15 drops/mL, priming volume: 23mL, length: 122in, CARESITE; Catalog Number: 480256. 24. 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; Catalog Number: 480258. 25. SPACE PUMP IV SET 15D, 90 IN.; SPACE PUMP IV SET 15D, 90 IN.; Catalog Number: 480263. 26. UNIV. 15 DROP PUMP SET W 3 CARESITE L.L.; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 490100. 27. 60 DROP METRISET PUMP SET, 3 CARESITES; Priming volume: 19mL, length: 120in, CARESITE; Catalog Number: 490101.

Recalling firm

B Braun Medical Inc

Quantity

49,330,370

Distribution

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Recall date

December 3, 2025

Classification

Class II

Status

Ongoing

Agency

FDA (device)