0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun ...

Published: April 29, 2026Recall ID: D-0497-2026Category: drugsCountry: US

Reason for Recall / Hazard

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

Field	Value
City	Allentown
State	PA
Openfda › Unii	451W47IQ8X
Openfda › Route	IRRIGATION
Openfda › Rxcui	486515
Openfda › Spl id	69f7d8f6-65cd-45bd-83f7-7249905a2e72
Openfda › Brand name	SODIUM CHLORIDE FOR IRRIGATION
Openfda › Spl set id	5bd9b176-0402-4a3f-a6b4-c3f393fc092a
Openfda › Package ndc › 1	0264-7388-50
Openfda › Package ndc › 2	0264-7388-60
Openfda › Product ndc	0264-7388
Openfda › Generic name	SODIUM CHLORIDE FOR IRRIGATION
Openfda › Product type	HUMAN PRESCRIPTION DRUG
Openfda › Substance name	SODIUM CHLORIDE
Openfda › Manufacturer name	B. Braun Medical Inc.
Openfda › Application number	NDA016733
Openfda › Is original packager	true
Event id	98693
Address 1	861 Marcon Blvd
Address 2	N/A
Code info	Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
Postal code	18109-9577
Report date	20260429
Product type	Drugs
Product quantity	124,244 bags
Reason for recall	Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20260402
Initial firm notification	Letter
Center classification date	20260428