Reported Dec 3, 2025 · Ongoing

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's…

B Braun Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

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

5 of 5 products

Products covered by this recall
Model / number	Product as published
`490528.`	IV ADMIN SET 15 DROP W/ CARESITE EXT SET
`490550.`	111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET
`490605.`	IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.
`490616.`	IV SET 15 DR 3CARESITE 2 ULTRAPORT
`490654.`	IV ADMIN SET, 2 CARSITE LADS

Lot codes and dates: 5 of 5 products
Products covered by this recall
Model / number Barcodes Product as published
490528 0404695520328404046955203277 Primary UDI-DI: 04046955203284; Unit of Dose UDI-DI: 04046955203277; Expiration Date: Earliest Exp of Comp or 36mths.
490550 0404695527034704046955270330 Primary UDI-DI: 04046955270347; Unit of Dose UDI-DI: 04046955270330; Expiration Date: Earliest Exp of Comp or 24mths.
490605 0404695535287604046955352869 Primary UDI-DI: 04046955352876; Unit of Dose UDI-DI: 04046955352869; Expiration Date: Earliest Exp of Comp or 36mths.
490616 0404695566469604046955664689 Primary UDI-DI: 04046955664696; Unit of Dose UDI-DI: 04046955664689; Expiration Date: Earliest Exp of Comp or 36mths.
490654 0404695583636904046955836352 Primary UDI-DI: 04046955836369; Unit of Dose UDI-DI: 04046955836352; Expiration Date: Earliest Exp of Comp or 36mths.
Amount recalled: 190,625 units

The agency filed one notice per product. You are reading one of them; the other 115 are below.

103 more are in the archive.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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25 in total.

Model / number	Barcodes	Product as published
`490528`	`0404695520328404046955203277`	Primary UDI-DI: 04046955203284; Unit of Dose UDI-DI: 04046955203277; Expiration Date: Earliest Exp of Comp or 36mths.
`490550`	`0404695527034704046955270330`	Primary UDI-DI: 04046955270347; Unit of Dose UDI-DI: 04046955270330; Expiration Date: Earliest Exp of Comp or 24mths.
`490605`	`0404695535287604046955352869`	Primary UDI-DI: 04046955352876; Unit of Dose UDI-DI: 04046955352869; Expiration Date: Earliest Exp of Comp or 36mths.
`490616`	`0404695566469604046955664689`	Primary UDI-DI: 04046955664696; Unit of Dose UDI-DI: 04046955664689; Expiration Date: Earliest Exp of Comp or 36mths.
`490654`	`0404695583636904046955836352`	Primary UDI-DI: 04046955836369; Unit of Dose UDI-DI: 04046955836352; Expiration Date: Earliest Exp of Comp or 36mths.