Events

Recall of Device Recall ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31351
  • Event Risk Class
    Class 2
  • Event Number
    Z-0655-05
  • Event Initiated Date
    2005-02-28
  • Event Date Posted
    2005-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37840
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Clip, Implantable - Product Code FZP
  • 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.
  • Action
    The recalling firm sent a letter, dated 2/28/05 to consignees.

Device

Device Recall ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200.
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200. Ten cartridges are packaged per box.
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery
  • Manufacturer Address
    Ethicon Endo-Surgery, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Source
    USFDA