DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date C
FDA device recall Z-2212-2016 · posted 2016-07-22 · Terminated
Recall details
- Recalling firm
- Carefusion 2200 Inc
- Reason for recall
- BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
- Action taken
- BD, sent an "URGENT: Medical Device/ Safety Alert/Recall Notification" letter dated 6/30/2016 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the affected units, along with the enclosed CUSTOMER RESPONSE FORM to: BD formerly CareFusion, 75 North Fairway Drive, Vernon Hills, Illinois, 60061 Attn: Customer Advocacy; to expedite the correction process and acknowledge receipt of the notification. The firm will issue a credit upon receipt of the returned affected product. For questions and support 1-800-323-9088 Prompt 3 or email: GMB-US-Complaint-Intake@carefusion.com.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 10
- Distribution
- Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
- Date initiated
- 2016-07-01
- Date posted
- 2016-07-22
- Date terminated
- 2017-03-29
- Location
- Vernon Hills, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LAPAROSCOPIC RETRACTORS (K092684) | Cardinal Health, Inc. | 2010-01-22 |