Recall Z-0013-2012 ยท EXB Collector, Ostomy
Convatec Inc.
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
| Date | Oct 5, 2011 (initiated Jun 22, 2011) |
| Status | Terminated |
| Reason | Post-operative kits 57 mm may contain 70 mm pouches. |
| Root cause | Labeling mix-ups |
| Action | The firm, ConvaTec, sent a "MEDICAL DEVICE RECALL" letter dated June 22, 2011 via UPS 2nd day air to all customers and sales representatives that received product. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop distributing and quarantine the recalled lot; perform a count of recalled product currently in inventory; complete and return the Recall Response Form via fax to (908) 904-2120 or mail to 200 Headquarters Park Drive, Skillman, New Jersey 08558; return the Recall Response Form even if no recalled product is in invento |
| Quantity | 283 units |
| Distribution | Nationwide distribution: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.