Surgical drapes recalled over sterilization equipment calibration issues
Medline is recalling 14,927,765 units of surgical drapes because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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: Scored 3 under the risk-of-harm criterion: the firm states the calibration issues have the potential to impact the sterility assurance level of products used in sterile procedures, and no injuries are reported.
Plain-English summary
Medline surgical drapes are being recalled by Medline Industries, LP, covering drape sheets under model numbers DYNJP2410, DYNJP2411 and DYNJP2412, among the model numbers listed in the enforcement record.
The record states Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. It states all products were exposed to the validated sterilization and packaging cycles, however the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
The record lists 14,927,765 units, with model numbers, UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
A sterility assurance level that cannot be relied on carries an infection risk for products used in sterile procedures. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Medline's instructions.
The recalled product
- Product
- Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
- Manufacturer
- Medline Industries, LP
- Affected units
- 14,927,765
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)
- 1) DYNJP2410
- UDI-DI: 10080196739691(each)
- 40080196739692(case)
- Lot Number: 30525050127
- 2) DYNJP2410
- Lot Number: 30525070161
- 3) DYNJP2410
- Lot Number: 30525070250
- 4) DYNJP2410
- Lot Number: 30525060147
- 5) DYNJP2410
- Lot Number: 30522030151
- 6) DYNJP2410
- Lot Number: 30522070033
- 7) DYNJP2410
- Lot Number: 30522080015
- 8) DYNJP2410
- Lot Number: 30522080067
- 9) DYNJP2410
- Lot Number: 30522090028
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP 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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