SCPC
SICHUAN PHARMACEUTICAL.INC · Model Ear Loops, Flat Pleated, 3 layers · UDI-DI 06941548991327
Description
The Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The surgical masks is held over the user’s mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.
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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