Recall Z-2951-2018
Haemonetics Corporation · initiated July 13, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Codes / lots: Lot # 1117066
Reason for recall
OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
FDA-determined cause: Process control
Action taken
The firm, Haemonetics, notified customers by an email titled "URGENT: MEDICAL DEVICE RECALL" on July 13, 2018 . The email described the product, problem, and actions to be taken. The customers were instructed to inspect product for defect and return units of the affected lots for replacement with non-affected units; complete the attached customer acknowledgement form via FAX TO +1-781-356-3558 OR SCAN AND E-MAIL TO: CORPORATEREGULATORY@HAEMONETICS.COM. You can contact your local customer service representative at: North America 1.800.537.2802 or email:customerservicena@haemonetics.com.
Details
- Recall number
- Z-2951-2018
- Initiated
- July 13, 2018
- Terminated
- June 16, 2020
- Product code
- CAC – Apparatus, Autotransfusion
- Quantity
- 348 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Haemonetics Corporation, Braintree, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2950-2018 Class II | Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic…OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the… | 07/13/2018Terminated |