Home / Recalls / ConvaTec, Inc / Z-1035-2019

Z-1035-2019 Class II Ongoing

Recalled by ConvaTec, Inc — Greensboro, NC

FDA device recall Z-1035-2019 was initiated by ConvaTec, Inc on January 9, 2019 and is designated Class II. Reason for recall: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. The recall status is ongoing. Affected quantity: 24,822,068 devices total.

Recall Details

Product Type
Devices
Report Date
March 27, 2019
Initiation Date
January 9, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,822,068 devices total

Product Description

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.

Reason for Recall

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Distribution Pattern

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.

Code Information

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

Other recalls by ConvaTec, Inc

  • Z-2677-2026 Class II — Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R (June 8, 2026)
  • Z-1582-2026 Class II — Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm (February 16, 2026)
  • Z-1584-2026 Class II — Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm (February 16, 2026)
  • Z-1583-2026 Class II — Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm (February 16, 2026)
  • Z-0160-2026 Class II — DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings (August 29, 2025)
  • Z-0903-2025 Class II — Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two- (November 29, 2024)
  • Z-1495-2024 Class II — ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control D (February 27, 2024)
  • Z-1350-2024 Class II — Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 42364 (February 19, 2024)
  • Z-1276-2024 Class II — ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, (January 17, 2024)
  • Z-0723-2023 Class II — ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive (November 15, 2022)

FDA data resources