Medline Medcrest surgical gowns may delaminate prematurely after recommended laundering
Medline is recalling Medcrest surgical gowns because the fabric may delaminate prematurely when the included laundering instructions are followed.
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: 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 Medline Medcrest surgical gowns across nine product codes, covering critical cover and panel cover level 4 gowns in sizes L to 5XL. About 104,004 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 gowns by the product codes and UDIs above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical gown
- Affected units
- 104,004
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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