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.
This recall has been terminated (originally issued February 21, 2003).
- Company
- Symbiosis Corp.
- Recall Initiated
- September 3, 2002
- Posted
- February 21, 2003
- Terminated
- April 15, 2008
- Recall Number
- Z-0562-03
- Quantity
- 155/5-pack
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Product does not have the needle component as part of the jaw assembly.
Distribution
Product was distributed to 29 hospital accounts nationwide. There were no intenational, govenment or military accounts.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.
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