Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUE
FDA device recall Z-1666-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- Tubing connectors incorrectly packaged and labeled.
- Action taken
- The firm, Maquet, sent a "PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: whitney.torning@maquet.com. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 40 BEQ-HG 0284 3/8" x 3/8" Lot 70041098 Connectors
- Distribution
- Nationwide distribution: USA state of CA.
- Date initiated
- 2011-02-23
- Date posted
- 2011-03-16
- Date terminated
- 2012-09-13
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HLM TUBING SET WITH BIOLINE COATING (K080592) | Maquet Cardiopulmonary, AG | 2008-09-11 |