CLASS II Drug recall · Reported 7 Mar 2018 · FDA Enforcement Report

0.9% Sodium Chloride Irrigation USP (PIC) recalled by B. Braun Medical

B. Braun Medical is recalling 0.9% Sodium Chloride Irrigation USP (PIC), distributed nationwide in the US. The recall was initiated on 16 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch # J7N912, Exp 10/31/20

NDC0264-2201

Quantity recalled17,360 plastic irrigation containers

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0549-2018
FDA event ID: 79348
Recalling firm: B. Braun Medical, Irvine, CA
Brand: Sodium Chloride
Manufacturer: B. Braun Medical Inc.
Classification: Class II
Status: Terminated
Recall initiated: 16 Feb 2018
FDA classified: 27 Feb 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

16 Feb 2018	Recall initiated by company
27 Feb 2018	Classified by FDA	+11 days
7 Mar 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.

Product as listed by the FDA

0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Batch # J7N912, Exp 10/31/20

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from B. Braun Medical

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Other Sodium Chloride recalls

All 132

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
13 May 2026Drug	CLASS I	Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation	B Braun Medical	Sterility	Nationwide
22 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride	Huons	Sterility	Nationwide