Prep-Fill Guarded Luer Connector recall: Sterility Concern
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W…
Why was Prep-Fill Guarded Luer Connector recalled?
Blister package had an unsealed edge compromising sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. Part 57-400 - Lot numbers 45266, 44549, 44120, 43800, 43626, 42634, 42236, 39350, 37176, 36596, 33074. UDI: B212574001. b. Part 57-400W - Lot numbers 39371, 37093, 37086, 37079, 39378, 39364, 39357, 36558. UDI: B21257400W1. c. Part 57-401 - Lot numbers 45047, 43633. UDI: B212574011. d. Part 57-402 - Lot number 37151. UDI: B212574021.
- Product
- Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W…
- Recalling firm
- International Medical Industries, Inc.
- Quantity
- 228,000 DEVICES
- Distribution
- US Nationwide Distribution was made to AR, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, MD, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, PA, SC, TX, and VA. There was no government/military/foreign distribution.
- Recall date
- January 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)