Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units
FDA device recall Z-1591-2011 · posted 2011-03-07 · Terminated
Recall details
- Recalling firm
- Anchor Products Company, Inc.
- Reason for recall
- 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.
- Action taken
- 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 each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 2,256 units
- Distribution
- Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.
- Date initiated
- 2010-12-09
- Date posted
- 2011-03-07
- Date terminated
- 2012-01-20
- Location
- Addison, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM (K061555) | Anchor Products Co. | 2006-08-31 |