Extension Set utilized in gravity IV administration recall
Extension 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 numbers: 1. EXTENSION SET, 18 IN; Catalog Number: 490448. 2. EXTENSION SET, 52 IN.; Catalog Number: 490465. 3. EXTENSION SET 49 IN.; Catalog Number: 490486. 4. EXTENSION SET, 12 CARESTITE LADS; Catalog Number: 490577.
Why was Extension Set utilized in gravity IV administration recalled?
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
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: 490448; Primary UDI-DI: 04046964848858; Unit of Dose UDI-DI: 04046964848841. Shelf Life: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490465; Primary UDI-DI: 04046964950735; Unit of Dose UDI-DI: 04046964950728. Shelf Life: Earliest Exp of Comp or 36mths. 3. Catalog Number: 490486; Primary UDI-DI: 04046964991257; Unit of Dose UDI-DI: 04046964991240. Shelf Life: Earliest Exp of Comp or 24mths. 4. Catalog Number: 490577; Primary UDI-DI: 04046955287536; Unit of Dose UDI-DI: 04046955287529. Shelf Life: Earliest Exp of Comp or 36mths.
- Product
- Extension 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 numbers: 1. EXTENSION SET, 18 IN; Catalog Number: 490448. 2. EXTENSION SET, 52 IN.; Catalog Number: 490465. 3. EXTENSION SET 49 IN.; Catalog Number: 490486. 4. EXTENSION SET, 12 CARESTITE LADS; Catalog Number: 490577.
- Recalling firm
- B Braun Medical Inc
- Quantity
- 43,452 units
- 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)