ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box.
- Company
- Ethicon Endo-Surgery
- Recall Initiated
- February 28, 2005
- Posted
- March 25, 2005
- Terminated
- February 21, 2007
- Recall Number
- Z-0657-05
- Quantity
- 7968 devices.
- Firm Location
- Cincinnati, OH
Reason for Recall
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
Distribution
The product was distributed throughout the United States and to foreign customers located in Saudi Arabia, Egypt, United Kingdom, Germany, France, Republic of Panama, Turkey, Hong Kong, Taiwan, Puerto Rico, Spain, Japan, China, Republic of Singapore, Argentina, Italy, New Zealand, Australia, Canada, Czech Republic, Sweden, Portugal, Slovenia, Poland, Hungary, and the United Arab Emirate.
Lot / Code Info
Lot: TE7978, exp. date 01/09; TE8279, exp. date 01/09; TE2018, exp. date 01/09; TG2223, exp. date 01/09; TG7067, exp. date 01/09; TL7643, exp. date 07/09; SK2036, exp. date 07/08; SL2110, exp. date 07/08; SM2078, exp. date 07/08; SM2353, exp. date 07/08; TA7932, exp. date 01/09; TB2334, exp. date 01/09; TE2375, exp. date 01/09; and TE2486, exp. date 01/09.
Root Cause
Other
Action Taken
The recalling firm sent a letter, dated 2/28/05 to consignees.