Recall Z-1590-2011 ยท GCJ Laparoscope, General & Plastic Surgery
Anchor Products Company, Inc.
Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surger
| Date | Mar 7, 2011 (initiated Dec 9, 2010) |
| Status | Terminated |
| Reason | The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage. |
| Root cause | Device Design |
| Action | The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited ea |
| Quantity | 88,785 units |
| Distribution | Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061555 | ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM Anchor Products Co., Aug 31, 2006 |