Recall Z-3079-2017 ยท FYA Gown, Surgical
Master & Frank (Pinghu) Co., Ltd.
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
| Date | Jun 1, 2017 |
| Status | Open, Classified |
| Reason | The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam. |
| Root cause | Other |
| Action | Master & Frank Enterprise Co., LTD is working directly with Medline Industries, Inc., on this recall. A written notification was emailed to Medline Industries, Inc. on June 1, 2017 notifying them of the recall and further instructions. Consignee was instructed to quarantine and destroy any recalled product and to respond to the recall communication. The attached recall response form requested that the consignee notify all of their own customers of the recall. |
| Quantity | 2,160 units |
| Distribution | Domestic: IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS Medline Industries, Inc., Feb 25, 1997 |