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.
Reported: March 7, 2018 Initiated: February 16, 2018 #D-0549-2018
Product Description
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.
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.
Details
- Recalling Firm
- B. Braun Medical Inc
- Units Affected
- 17,360 plastic irrigation containers
- Distribution
- Nationwide in the USA
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by B. Braun Medical Inc. Units affected: 17,360 plastic irrigation containers.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 7, 2018. Severity: Moderate. Recall number: D-0549-2018.
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