Reported Dec 3, 2025 · Ongoing

SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat…

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

3 of 3 products

Products covered by this recall
Model / number	Product as published
`352604.`	UNIVERSAL IV ADMIN SET
`NF1251.`	SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites
`NF1290.`	SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites

Lot codes and dates: 3 of 3 products
Products covered by this recall
Model / number Barcodes Product as published
352604 0404696418187004046964181863 Primary UDI-DI: 04046964181870; Unit of Dose UDI-DI: 04046964181863; Expiration Date: Earliest Exp of Comp or 60mths.
NF1251 0404696418710004046964187094 Primary UDI-DI: 04046964187100; Unit of Dose UDI-DI: 04046964187094; Expiration Date: Earliest Exp of Comp or 60mths.
NF1290 0404696418714804046964187131 Primary UDI-DI: 04046964187148; Unit of Dose UDI-DI: 04046964187131; Expiration Date: Earliest Exp of Comp or 60mths.
Amount recalled: 46,250 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
`352604`	`0404696418187004046964181863`	Primary UDI-DI: 04046964181870; Unit of Dose UDI-DI: 04046964181863; Expiration Date: Earliest Exp of Comp or 60mths.
`NF1251`	`0404696418710004046964187094`	Primary UDI-DI: 04046964187100; Unit of Dose UDI-DI: 04046964187094; Expiration Date: Earliest Exp of Comp or 60mths.
`NF1290`	`0404696418714804046964187131`	Primary UDI-DI: 04046964187148; Unit of Dose UDI-DI: 04046964187131; Expiration Date: Earliest Exp of Comp or 60mths.