LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical I...

Published: April 29, 2026Recall ID: D-0498-2026Category: drugsCountry: US

Reason for Recall / Hazard

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

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

Field	Value
City	Allentown
State	PA
Openfda › Unii › 1	M4I0D6VV5M
Openfda › Unii › 2	660YQ98I10
Openfda › Unii › 3	451W47IQ8X
Openfda › Unii › 4	TU7HW0W0QT
Openfda › Route	IRRIGATION
Openfda › Rxcui	847628
Openfda › Spl id	4bf1e3a5-1742-4843-ad41-f4e7c9c2936e
Openfda › Brand name	LACTATED RINGERS IRRIGATION
Openfda › Spl set id	0db56c7a-2b8f-4593-8591-2c481c92b2cf
Openfda › Package ndc	0264-7389-60
Openfda › Product ndc	0264-7389
Openfda › Generic name	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE
Openfda › Product type	HUMAN PRESCRIPTION DRUG
Openfda › Substance name › 1	CALCIUM CHLORIDE
Openfda › Substance name › 2	POTASSIUM CHLORIDE
Openfda › Substance name › 3	SODIUM CHLORIDE
Openfda › Substance name › 4	SODIUM LACTATE
Openfda › Manufacturer name	B. Braun Medical Inc.
Openfda › Application number	NDA018681
Openfda › Is original packager	true
Event id	98693
Address 1	861 Marcon Blvd
Address 2	N/A
Code info	Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
Postal code	18109-9577
Report date	20260429
Product type	Drugs
Product quantity	54,540 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