Medline Proxima sterile surgical drapes recalled due to potential packaging breach
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a potential packaging breach of sterile surgical drapes with no reported illnesses or injuries. As a risk-of-harm medical device where injury has not yet been reported, it meets the High (3) severity criterion.
Plain-English summary
Medline Industries, LP is recalling 1,482 units of Proxima sterile surgical drapes that were distributed nationwide. The Proxima Drape product line includes multiple configurations designed for different surgical procedures, including cesarean sections, laparoscopic cholecystectomy, abdominal surgery, orthopedic procedures, and robotic surgery.
The recall was initiated due to a potential breach in pouch packaging that could lead to loss of sterility. Breaches in sterile packaging can compromise the sterile barrier that protects surgical drapes from contamination.
The affected products were distributed across the United States to healthcare facilities and surgical centers. These facilities should verify the status of any Proxima Drape products they may have received.
Facilities that have received these drapes should contact Medline Industries for guidance regarding the specific lot numbers and item numbers involved in this recall.
The recalled product
- Product
- Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Drapes
- Hazard
- packaging-breach
- sterility-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Item No. DYNJCDCSEC01
- DYNJP2498
- DYNJP3102A
- DYNJP3103
- DYNJP4014
- DYNJP4015
- DYNJP4124
- DYNJP6108
- DYNJP8005UG
- DYNJP8303
- DYNJP8304A
- DYNJP9108
- UDI (case): 40888277367679
- 40080196739494
- 40080196778363
- 40080196744221
- 40080196287308
- 40080196770039
- 40080196164944
- 20888277668840
Distribution
Distributed nationwide across the United States.
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