Z-0562-03
Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length...
Boston Scientific Corporation / initiated 2002-09-03 / Terminated
Symbiosis Corp. began a recall of Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is... on . The reason FDA records is "Product does not have the needle component as part of the jaw assembly". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0562-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is pakaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box.
- Reason for recall
- Product does not have the needle component as part of the jaw assembly.
- FDA root cause
- Other
- Action
- The firm forwarded recall letters and response forms via Federal Express to Risk Managers at hospitals on 9/3/2002. Accounts were asked to return product by first calling 1-800-862-1284.
- Quantity in commerce
- 155/5-pack
- Distribution
- Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.
- Product codes and lots
- The code for the individual pouches is Catalog 1589 and Lot # 0551847, expiration date of 2005-07. The code for the five pack boxes is Catalog No. 1589 and lot number 0551847, expiration date of 2005-07.
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