Z-1875-2020Class II
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch
Maquet Cardiovascular LLC / initiated 2020-04-07 / Terminated / root cause: manufacturing process
Maquet Cardiovascular, LLC began a recall of HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries... on . FDA classified it as Class II and gives the reason as "Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1875-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Maquet Cardiovascular LLC
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- Product code
- MAL Graft, Vascular, Synthetic/Biologic Composite
- Reason for recall
- Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- Getinge issued a customer notification - Urgent Medical Device Removal on April 7, 2020 via FedEx 2-day delivery with signature required. Letter states reason for recall, health risk, and action to take: Examine your inventory immediately to determine if you have any affected HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft and/or HEMASHIELD PLATINUM Woven Double Velour Vascular Graft products. If you have affected product that are listed in attachment 1 on page 5, please remove the affected products from areas of use. "If you have affected product to return, please contact Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. Please fill out the customer response form on page 4 with the required information. "Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided. Please arrange for pickup with the designated delivery service provider. Whether you have the affected product or not, please complete and return the form (page 4) to acknowledge this recall by e-mailing a scanned copy to [email protected] or by faxing the form to (973) 807-9205 Questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
- Product codes and lots
- Serial Numbers: 1069033761 1069030839 1071600069 1071620833 1071615770 1071620950 1074557517 1074562931 1077531880 1109551893 1109625685 1113411073 1115932310 1160529586 1160492194 1160491552 1160727457 1160529957 1182769563 1182780936 1182789351 1182792017 1183481796 1069032514 1115876907 1115936362 1137588685
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1859-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1860-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1861-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1862-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1863-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1864-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1865-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1866-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1867-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1868-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1869-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1870-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1871-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1872-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1873-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1874-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1875-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1876-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1877-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1878-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1879-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1880-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1881-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1882-2020 | Class II | Terminated | Voluntary: Firm initiated |
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