Recall Z-1422-2012 ยท KDD Kit, Surgical Instrument, Disposable
Deroyal Industries, Inc. Lafollette
Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO,
| Date | Apr 17, 2012 (initiated Feb 7, 2012) |
| Status | Terminated |
| Reason | Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable. |
| Root cause | Nonconforming Material/Component |
| Action | DeRoyal Industries sent a Recall of Episeal Wound Closure Strip letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. Please identify and quarantine any affected inventory using the product and lot numbers listed above. 2. Render affected product unusable, destroy and discard according to your facilitys guidelines. 3. If you are a distributor, forward this recall to any of your end users that may have affected product or provide us |
| Quantity | 42941 units distributed |
| Distribution | Worldwide Distribution -- USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.