Medline Industries, LP: 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 C

Hazard

Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

Details from the source

Reason for recall: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection. Distribution: Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada. Quantity: 104,004 Lot/code info: UDI-DI (each/case) 10197344014002 20197344014009 10888277189188 40888277189189 10884389189191 40884389189192 10884389193297 40884389193298 10888277189218 40888277189219 10884389189221 40884389189222 10193489040111 20193489040118 10884389189221 40884389189222 10193489021820 20193489021827 All lots affected

UPC codes

10197344014002, 20197344014009, 10888277189188, 40888277189189, 10884389189191, 40884389189192, 10884389193297, 40884389193298, 10888277189218, 40888277189219, 10884389189221, 40884389189222, 10193489040111, 20193489040118, 10193489021820, 20193489021827

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.