Recall Z-2757-2017— Cardinal Health 200, LLC
Class II · Terminated
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2017-06-27, terminated 2019-03-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.. Reason: Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-27
- Terminated
- 2019-03-29
- Firm location
- Waukegan, IL, United States
Product description
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Reason for recall
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
Data sourced from openFDA. This site is unofficial and independent of the FDA.