FDA · Medical device recall

ABSOLOK Extra Absorbable Ligating Clip cartridges… and 3 more products

March 25, 2005

Date posted by the FDA: March 25, 2005
Status: Terminated
Filed by: Ethicon Endo-Surgery
Reason: 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 pattern: 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.

4 products in this recall

ABSOLOK Extra Absorbable Ligating Clip cartridges…

Product: ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100. Ten cartridges are packaged per box.
Quantity: 10,470 boxes.
Codes and lots: Lot: SL2102, exp. date 07/08; SL2116, exp. date 07/08; SL2123, exp. date 07/08; SM7266, exp. date 07/08; SP2618, exp. date 07/08; TB2043, exp. date 01/09; TB2044, exp. date 01/09; TB2199, exp. date 01/09; TB2333, exp. date 01/09; TB7971, exp. date 01/09; TD7873, exp. date 01/09; TG8166, exp. date 01/09; TJ2047, exp. date 07/09; TJ2331, exp. date 07/09; TJ8306, exp. date 07/09; TK8398, exp. date 07/09; TL2243, exp. date 07/09; TL2352, exp. date 07/09; and TP7672, exp. date 07/09.
Recall started: Feb. 28, 2005
Device type: Clip, Implantable
Root cause (FDA): Other
What the company told customers: The recalling firm sent a letter, dated 2/28/05 to consignees.
Recall number: Z-0654-05

ABSOLOK Extra Absorbable Ligating Clip cartridges…

Product: ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200. Ten cartridges are packaged per box.
Quantity: 23,046 boxes.
Codes and lots: Lot: SK2046, exp. date 07/08; SK2054, exp. date 07/08; SL2103, exp. date 07/08; SL2111, exp. date 07/08; SL2112, exp. date 07/08; SL2117, exp. date 07/08; SL2128, exp. date 07/08; SM2549, exp. date 07/08; SM2621, exp. date 07/08; TA2977, exp. date 01/09; TA7272, exp. date 01/09; TA7585, exp. date 01/09; TB2644, exp. date 01/09; TB7702, exp. date 01/09; TC2648, exp. date 01/09; TC7050, exp. date 01/09; TD2574, exp. date 01/09; TE2828, exp. date 01/09; and TE7186, exp. date 01/09; TG2562, exp. date 01/09; TG2789, exp. date 01/09; TH2052, exp. date 07/09; TH2350, exp. date 07/09; TH7091, exp. date 07/09; TJ2137, exp. date 07/09; TJ2506, exp. date 07/09; TJ7414, exp. date 07/09; TJ8542, exp. date 07/09; TK8399, exp. date 07/09; TL2620, exp. date 07/09; TL7452, exp. date 07/09; TP7673, exp. date 07/09; UA2003, exp. date 01/10; UA2244, exp. date 01/10; UA2309, exp. date 01/10; UA2440, exp. date 01/10; UA2608, exp. date 01/10; UA2822, exp. date 01/10; and UA2823, exp. date 01/10.
Recall started: Feb. 28, 2005
Device type: Clip, Implantable
Root cause (FDA): Other
What the company told customers: The recalling firm sent a letter, dated 2/28/05 to consignees.
Recall number: Z-0655-05

ABSOLOK Extra Absorbable Ligating Clip cartridges…

Product: ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten cartridges are packaged per box.
Quantity: 15,462 boxes.
Codes and lots: Lot: SK2037, exp. date 07/08; SK2055, exp. date 07/08; SL2104, exp. date 07/08; SL2118, exp. date 07/08; SL2445, exp. date 07/08; SM2135, exp. date 07/08; SP2530, exp. date 07/08; SP2711, exp. date 07/08; TA2840, exp. date 01/09; TB2335, exp. date 01/09; TC7957, exp. date 01/09; TD2044, exp. date 01/09; TD2280, exp. date 01/09; TD2664, exp. date 01/09; TD2938, exp. date 01/09; TE7512, exp. date 01/09; TG7713, exp. date 01/09; TG7825, exp. date 01/09; TG7936, exp. date 01/09; TK2477, exp. date 07/09; TK7626, exp. date 07/09; TL2169, exp. date 07/09; TL7265, exp. date 07/09; TP7279, exp. date 07/09; UA2517, exp. date 01/10; UA2747, exp. date 01/10; UA2932, exp. date 01/10; and UA7902, exp. date 01/10.
Recall started: Feb. 28, 2005
Device type: Clip, Implantable
Root cause (FDA): Other
What the company told customers: The recalling firm sent a letter, dated 2/28/05 to consignees.
Recall number: Z-0656-05

ABSOLOK Extra Absorbable Ligating Clip cartridges…

Product: ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box.
Quantity: 7968 devices.
Codes and lots: 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.
Recall started: Feb. 28, 2005
Device type: Clip, Implantable
Root cause (FDA): Other
What the company told customers: The recalling firm sent a letter, dated 2/28/05 to consignees.
Recall number: Z-0657-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0654-05, Z-0655-05, Z-0656-05, Z-0657-05. The agency record governs; check it and the company before acting.

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