Recall Z-2321-2008 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Medline Industries Inc
Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA, Made in China; reorder: NON21432RF
| Date | Sep 20, 2008 (initiated Jun 13, 2008) |
| Status | Terminated |
| Reason | There is the potential for the RF ID tag to separate from the retaining pouch. |
| Root cause | Device Design |
| Action | Initially a recall letter dated 6/13/08 was sent to the direct accounts identifying 5 lots of affected lots with two reorder numbers involved, explaining that there was a lack of integrity of the retaining pouch material for the RFID gauze, and that there was a potential for the RFID tag to separate from the retaining pouch during use. It was subsequently discovered that there was only one reorder number affected by the problem and that an additional lot had been gamma sterilized. Therefore a second letter dated 6/19/08, listing the correct reorder number and the six affected lots, was sent |
| Quantity | 295 cases |
| Distribution | California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061316 | MEDLINE SURGICAL SPONGE SCANNER Medline Industries, Inc., Nov 2, 2006 |