Gown, Surgical

See complete list in RES, exceeds character limit. Medline Surgical Gowns

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. 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.

Medline Surgical Packs:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. 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.

Medline Medcrest Surgical Gowns:

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.

Medline Surgical Gowns:

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. 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.

ChemoPlus gowns:

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

Surgical gowns were manufactured with the wrong sleeve.

Aero Blue Performance Surgical Gown, XL- Sterile surgical gown

Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric.

AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.