Medline surgical drapes may delaminate prematurely after recommended laundering
Medline is recalling five surgical drape products because the fabric may delaminate prematurely when the included laundering instructions are followed.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source describes a risk of surgical strikethrough and infection, and no injuries are stated.
Plain-English summary
Medline Industries, LP is recalling five Medline surgical drape products: table cover drapes MDTBTCS6070GN and MDTBTCS6090GN, underbuttock drape MDTDXUNDBGN, Mayo stand cover MDTMAYOXGN and pocket sheet MDTZ1003656GN. About 23,568 units were distributed nationwide in the United States and internationally to Panama, the United Arab Emirates, the Virgin Islands, Saudi Arabia, India, Chile and Canada. The FDA has classified this recall as Class II.
The fabric may experience premature delamination when using the included laundering instructions. Identifying a delaminated gown or drape in a surgical setting may result in a brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be a risk of infection.
All lots are affected, across the UDI-DIs listed in the FDA enforcement record.
Facilities can identify affected drapes by the product codes and UDIs above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical drape
- Affected units
- 23,568
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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Same hazard · fabric delamination
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