CCW
Qinhuangdao Taizhi Medical Technology Co., Ltd. · Model ear strap, 175×95mm · UDI-DI 06973274100520
Description
The Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users’ mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-08 | O&M HALYARD, INC. | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, |
| 2024-11-08 | O&M HALYARD, INC. | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-01-03 | Owens & Minor Distribution, Inc. | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops |
| 2019-10-11 | AMD Medicom Inc. | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a |
| 2019-10-11 | AMD Medicom Inc. | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a |
| 2013-05-15 | Maytex Corp | Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box |
| 2003-06-03 | Safco Dental Supply Co. Inc. | The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration. |
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