Reported Dec 3, 2025 · Ongoing

CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space…

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

8 of 8 products

Products covered by this recall
Model / number	Product as published
`354302.`	CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.
`354303.`	CARESAFE ADMIN SET w/15um FILTER, 104 IN
`354304.`	CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.
`354305.`	CARESAFE ADMIN SET w/15um FILTER, 114 IN
`354306.`	CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.
`354307.`	CARESAFE ADMIN SET w/15um FILTER, 110 IN
`354308.`	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.
`354310.`	CARESAFE ANESTH SET w/15um FILTER,134IN.

Lot codes and dates: 8 of 8 products
Products covered by this recall
Model / number Barcodes Product as published
354302 0404695525994604046955259939 Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939.
354303 0404695505242404046955052417 Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417.
354304 0404695525996004046955259953 Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953.
354305 0404695505244804046955052431 Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431.
354306 0404695525998404046955259977 Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977.
354307 0404695505246204046955052455 Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455.
354308 0404695526000304046955259991 Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991.
354310 0404695505292904046955052905 Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.
Amount recalled: 4,438 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
`354302`	`0404695525994604046955259939`	Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939.
`354303`	`0404695505242404046955052417`	Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417.
`354304`	`0404695525996004046955259953`	Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953.
`354305`	`0404695505244804046955052431`	Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431.
`354306`	`0404695525998404046955259977`	Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977.
`354307`	`0404695505246204046955052455`	Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455.
`354308`	`0404695526000304046955259991`	Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991.
`354310`	`0404695505292904046955052905`	Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.