Z-1336-2023Class II
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Maquet Cardiovascular LLC / initiated 2023-03-06 / Open, Classified / root cause: manufacturing process
Maquet Cardiovascular, LLC began a recall of VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 on . FDA classified it as Class II and gives the reason as "Some batches of product were not sterilized to their minimum sterilization specification". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1336-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Maquet Cardiovascular LLC
- Product
- VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
- Product code
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- Reason for recall
- Some batches of product were not sterilized to their minimum sterilization specification.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- An Urgent Medical Device Removal notification letter dated 3/3/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro lot(s) affected by this recall. Please, note that Distributed Affected Lot Number(s) appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of the Hemopro with the product code/lot number(s) listed in this notice. " Should you have any affected product lot(s) as listed in this notification, please stop using and remove the complete device from areas of use. If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. " Please forward this information to all current and potential Hemopro and Hemopro 2 users within your hospital / facility. " If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action. " Please contact Getinge Customer Service at 888-880-2874 between the hours of 6:00 a.m. and 5:00 p.m. Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. " Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet Cardiovascular, LLC /Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-800-385-0294 . We apologize for any inconvenience this recall may cause. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888)
- Quantity in commerce
- 2300 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, China.
- Product codes and lots
- UDI-DI: 00607567700406; Lot Numbers: 3000278401, 3000271148, 3000268643, 3000263026, 3000274504, 3000263925
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1335-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1336-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1337-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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