Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
This recall has been terminated (originally issued October 6, 2015).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- October 6, 2015
- Terminated
- June 27, 2016
- Recall Number
- Z-0194-2016
- Quantity
- 19,440 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Leakage from the inlet port of the 15L Cycler Drainage Bags.
Distribution
US Distribution and Internationally to Canada.
Lot / Code Info
H15C11095
Root Cause
Under Investigation by firm
Action Taken
Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.
More recalls by Baxter Healthcare Corp.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Product Usage:...
Nov 8, 2016
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -...
Sep 28, 2016
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Co...
Sep 28, 2016