Recall Z-1035-2019— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2019-01-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-01-09
- Firm location
- Greensboro, NC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.