Z-1881-2020Class II
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 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 Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of... 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-1881-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Maquet Cardiovascular LLC
- Product
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - 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: 1136650764 1136649656 1138918524 1139377657 1143579436 1143599946 1147678079 1152754107 1158302730 1159727382 1159721538 1163859207 1166883762 1172730370 1177896586 1138937162 1141871928 1148785668 1152764001 1158785925 1159740547 1163841540 1168007426 1177892046
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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