Proxima Drape sterile drapes recalled for potential packaging breach risk
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.
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: FDA Class II medical device recall for potential sterility breach in surgical drapes. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Medline Industries, LP is recalling Proxima Drape sterile surgical drapes in multiple configurations, including HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, and VEIN PACK. A total of 2,422 units have been identified as subject to this recall.
The recall was issued because of a potential breach in the pouch packaging of these drapes. A breach in the sterile packaging could lead to loss of sterility, which could compromise the safety and effectiveness of the surgical drapes if used in sterile procedures.
The affected drapes were distributed nationwide throughout the United States. Healthcare facilities and surgical centers that received these products should check the lot numbers and UDI codes in the FDA's recall notice.
Consumers and healthcare facilities should stop using the affected products immediately and contact Medline Industries for instructions on return or disposal.
The recalled product
- Product
- Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Drape
- Affected units
- 2,422
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. DYNJ35520B
- DYNJ38529F
- DYNJ43406F
- DYNJ43421D
- DYNJ69185A
- DYNJ69340B
- DYNJ88923
- UDI (case): 40198459106904
- 40195327693870
- 40198459074005
- 40198459074784
- 40195327582839
- 40198459026127
- 40198459216856
- UDI (each): 10198459106903
- 10195327693879
- 10198459074004
- 10198459074783
- 10195327582838
- 10198459026126
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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