Drug recall: 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc.…

Class II FDA enforcement event 79348. Recall start date: 16 Feb 2018. Status in the FDA record: Terminated. Termination date: 23 Jan 2020.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

B. Braun Medical Inc started this drug recall on 16 Feb 2018. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 79348 has 1 product record. The first FDA enforcement report date is 7 Mar 2018. The record gives the status Terminated, with the termination date 23 Jan 2020.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA

Recalling firm

B. Braun Medical Inc, Irvine, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 79348: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0549-2018	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.	17,360 plastic irrigation containers	Class II	Terminated	7 Mar 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2018: 367
Share of these events in Class II: 60%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 90

Other events of the firm

Other FDA enforcement events of B. Braun Medical Inc
Initiated	Product (first record)	Type	Class	Records
19 Aug 2026	0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc	Drug	Class I	1
12 Aug 2026	Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-35	Drug	Class I	1
4 Aug 2026	Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025	Device	Class II	1
6 May 2026	Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867);	Device	Class I	3
28 Apr 2026	Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0	Drug	Class I	1
2 Apr 2026	Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801	Drug	Class II	4
19 Mar 2026	B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.	Device	Class I	6
2 Feb 2026	Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N	Device	Class II	3
29 Jan 2026	Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Vers	Device	Class II	8
29 Oct 2025	ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar	Device	Class II	116

B. Braun Medical Inc: all 90 events

Official channels

FDA enforcement report D-0549-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 79348. https://recallregister.com/fda/ii/79348/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA
What quantity of product is in FDA event 79348?: The FDA record gives this quantity: 17,360 plastic irrigation containers
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 60% of the 367 drug events that started in 2018 are in Class II.