Z-1329-2018 Class II Terminated
FDA device recall Z-1329-2018 was initiated by Arrow International Inc on December 22, 2017 and is designated Class II. Reason for recall: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. The recall status is terminated (terminated May 27, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- December 22, 2017
- Termination Date
- May 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-KH; (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-LC; (4) PSI Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-PHP; (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09907-LGH1; (6) Arrow PSI Kit, Part Number: CDC-09803-1A; (7) Arrow PSI Kit, Part Number: CDC-09903-1A
Reason for Recall
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Distribution Pattern
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Code Information
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