Recall Z-1610-2011 ยท EXB Collector, Ostomy
Convatec Inc.
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.
| Date | Mar 8, 2011 (initiated Feb 1, 2011) |
| Status | Terminated |
| Reason | Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together. |
| Root cause | Employee error |
| Action | Convatec sent a Medical Device Recall letter dated February 1, 2011, via UPS with return response forms attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop distributing and quarantine the recalled lot (0100814). Perform a count of recalled product currently in inventory. Complete the enclosed Recall Response Form and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. Ensure that their |
| Quantity | 77 market units |
| Distribution | Nationwide Distribution including AZ, IL, KS, MA, MI, NC, OK, OR, PA, SC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.