—#138023

Product

Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

FDA product code: GBZ — Catheter, Cholangiography
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K831931
Affected lot / code info: Lot Number : ME215673 EXp: 2019/09

Why it was recalled

Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter

Root cause (FDA determination)

Employee error

Action the firm took

Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).

Recalling firm

Firm: Atrium Medical Corporation
Address: 5 Wentworth Dr, Hudson, New Hampshire 03051-4929

Distribution

Distribution pattern: AZ, CA, LA. IN, NC, TN, TX, VA

Timeline

Recall initiated: 2015-06-19
Posted by FDA: 2015-08-05
Terminated: 2016-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.