Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.
- Company
- Convatec, Inc
- Recall Initiated
- January 9, 2019
- Recall Number
- Z-1035-2019
- Quantity
- 24,822,068 devices total
- Firm Location
- Greensboro, NC
Reason for Recall
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Distribution
Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.
Lot / Code Info
Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969
Root Cause
Package design/selection
Action Taken
ConvaTec notified customers on about 01/09/2019 via "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Instructions included how to identify affected product on the primary packaging and/or shipping carton as well as specific instructions for distributors, retailers, and end users (hospitals, EMT services, others). Distributors were instructed to inspect their inventory for affected products, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-582-6514 or ushcreturns@ups.com to report affected inventory on hand, forward the recall notice package to customers if product was further distributed, and provide a complete list of all consignees to allow ConvaTec to perform effectiveness checks. Retailers were instructed to immediately stop distributing and quarantine any affected inventory, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-582-6514 or ushcreturns@ups.com to report affected inventory on hand, and post page one of the recall notice in a conspicuous location in the store. End users (hospitals, EMT service, others) were instructed to inspect inventory to confirm if any affected product codes are in inventory, perform a count of affected product in inventory, complete and return the response form, contact Customer Service at 1-800-422-8811 or ushcreturns@ups.com to report affected inventory on hand.