(1) Arterial Catheterization Kit recall: Sterility Concern
(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial…
Why was (1) Arterial Catheterization Kit recalled?
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot Numbers: (1) 13F17D0198, 13F17F0215; (2) 13F17E0029, 13F17E0537; (3) 13F17B0226, 13F17D0017, 13F17D0280; (4) 13F17A0122, 13F17C0342, 13F17E0364, 13F17E0827
- Product
- (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial…
- Recalling firm
- Arrow International Inc
- Distribution
- Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
- Recall date
- April 18, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)