Recall Z-1074-03 ยท :
Rx Textiles Inc
PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.
| Date | Aug 1, 2003 (initiated Jun 11, 2003) |
| Status | Terminated |
| Reason | Product may not be sterile. |
| Root cause | Other |
| Action | Distributor was notified via email on 6/11/2003 and advised to quarantine the product. A follow up letter was sent via certified mail to the distributor and to the contract packer on 6/18/2003 with a questionnaire and a self addressed stamped envelope to verify effectiveness. |
| Quantity | 141 cases 25pk/Cs |
| Distribution | Product was shipped to one distribution center in CA who shipped product to consignees located in CA and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960803 | RX TEXTILES STERILE STOCKINETTE Rx Textiles, Inc., Jul 12, 1996 |