(1) Percutaneous Sheath Introducer Kit with Integral recall: Sterility Concern
(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with…
Why was (1) Percutaneous Sheath Introducer Kit with Integral 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) 13F17C0208, 13F17F0162; (2) 13F17F0231; (3) 13F17E0382, 13F17F0206; (4) 13F17D0049; (5) 13F17A0052, 13F17C0390; (6) 13F17A0123, 13F17E0014, 13F17E0455, 13F17F0289; (7) 13F16M0274, 13F17E0040, 13F17E0227, 13F17E0824
- Product
- (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with…
- 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)