Recalls / —
—#152793
Product
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
- FDA product code
- MMP — Cover, Barrier, Protective
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K041501
- Affected lot / code info
- Lot Numbers: 1112351 to 1609891
Why it was recalled
Sterility compromised due to breach in sterile barrier
Root cause (FDA determination)
Packaging process control
Action the firm took
Medtronic issued recall letter on January 23, 2017. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-23
- Terminated
- 2019-08-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.