Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARESAFE utilized in gravity IV administration sets and pump administration Recalled by B Braun Medical Inc Due to Potential for backflow of medication from secondary (piggyback)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact B Braun Medical Inc directly.
Affected Products
CARESAFE 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. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.; Catalog Number: 354302. 2. CARESAFE ADMIN SET w/15um FILTER, 104 IN; Catalog Number: 354303. 3. CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.; Catalog Number: 354304. 4. CARESAFE ADMIN SET w/15um FILTER, 114 IN; Catalog Number: 354305. 5. CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.; Catalog Number: 354306. 6. CARESAFE ADMIN SET w/15um FILTER, 110 IN; Catalog Number: 354307. 7. CARESAFE" IV Administration Set with AirStop Filter, Not made with PVC or DEHP, 2 CARESITE¿ Injection Sites, 2 ULTRAPORT¿ High-FlowFour-Way Stopcocks; CARESAFE ANESTH SET W/AIRSTOP, 134 IN.; Catalog Number: 354308. 8. CARESAFE ANESTH SET w/15um FILTER,134IN.; Catalog Number: 354310.
Quantity: 4,438 units
Why Was This Recalled?
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Where Was This Sold?
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
About B Braun Medical Inc
B Braun Medical Inc has 148 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report