Z-2560-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- May 2, 2018
- Termination Date
- July 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13210
Product Description
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
Reason for Recall
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Distribution Pattern
U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
Code Information
Lot #: 1) a) 18037128, 18057123; b) 18026062, 18026063; c) 18050076, 18092077; 2) a) 17303409, 17313728, 17324971, 17324972, 17340309, 17340310, 17355684; b) 17303412, 17311642, 17335910, 17340312, 17340314, 17355685, 17355686, 17355687; c) 17311643, 17314335, 17349257, 18026356, 18033604, 18047978, 18096513, 18110747; d) 17314337, 17321338, 17352567, 18005181