Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW recall: Sterility Concern
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS…
Why was Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW recalled?
Potential breach in pouch packaging which could lead to loss of sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item No. DYNJCDCSEC01, DYNJP2498, DYNJP3102A, DYNJP3103, DYNJP4014, DYNJP4015, DYNJP4124, DYNJP6108, DYNJP8005UG, DYNJP8303, DYNJP8304A, DYNJP9108; UDI (case): 40888277367679, 40080196739494, 40080196778363, 40080196744221, 40080196287308, 40080196770039, 40080196164944, 20888277668840, 40080196574125, 40080196771111, 40080196292432, 40080196152576; UDI (each): 10888277367678, 10080196739493, 10080196778362, 10080196744220, 10080196287307, 10080196770038, 10080196164943, 10888277668843, 10080196574124, 10080196771110, 10080196292431, 10080196152575; Lot No. 45024100168, 31124100039F, 31124090065F, 31124090066F, 31124090067F, 31124090068F, 45024090164, 31124090085F, 31124100084F, 45024100180, 72524050027, 72524060073, 31124090004H, 31124090045F, 45024100184, 45024100185.
- Product
- Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1,482 units
- Distribution
- US Nationwide distribution.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)