Recall Z-1722-2019— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2019-04-09, terminated 2020-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282. Reason: Affected products may have been manufactured with the catheter distal end hole too small.
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-09
- Terminated
- 2020-04-28
- Firm location
- Bloomington, IN, United States
Product description
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Reason for recall
Affected products may have been manufactured with the catheter distal end hole too small
Data sourced from openFDA. This site is unofficial and independent of the FDA.