Recall record at a glance
| Official record | Z-3079-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Master & Frank (Pinghu) Co., Ltd. |
| Report date | Sep 6, 2017 |
| Recall initiation date | Jun 1, 2017 |
| Quantity | 2,160 units |
| Location | Hangzhou, N/A, China |
Official product description
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.
Why the product was recalled
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.
Distribution information
Domestic: IL.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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