Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging
Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall addresses a potential breach in sterile surgical drape packaging that could lead to loss of sterility. No illnesses or injuries have been reported. This meets the High severity criterion as a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Medline Industries, LP (Northfield) is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The affected drapes include various surgical configurations such as basic drapes, IV drapes, setups without drapes, universal drapes, laparotomy packs, and cystoscopy packs used in operating rooms and surgical settings.
The recall affects 1,490 units distributed nationwide. The affected products are identified by item numbers DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, and DYNJP9120A, with specific lot numbers 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, and 31124100007F.
No illnesses or injuries have been reported to date in connection with this recall. Healthcare facilities should verify whether they have received the affected lot numbers and ensure that any such products are not used in surgical procedures.
The recalled product
- Product
- Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Drapes
- Affected units
- 1,490
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. DYNJP1020S
- DYNJP1025S
- DYNJP1040
- DYNJP1055S
- DYNJP3000
- DYNJP5050
- DYNJP6060S
- DYNJP9120A
- UDI (case): 40080196308126
- 40080196308133
- 40080196722892
- 40080196308195
- 40080196722946
- 40080196753391
- 40884389110295
- 40080196915416
- UDI (each): 10080196308125
- 10080196308132
- 10080196722891
- 10080196308194
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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