DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product… recallZ-2212-2016 · Carefusion 2200 Inc · initiated Jul 1, 2016
Class I Terminated All recalls posted in July 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carefusion 2200 Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Material/Component Contamination
What the company is doing
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: [email protected].
Recall details
- Recall number
- Z-2212-2016
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jul 1, 2016
- Posted by the FDA
- Jul 22, 2016
- Recalling firm
- Carefusion 2200 Inc
- Quantity
- 10
- Product code
- GCJ
- FDA submissions
- K092684
- Distribution
- Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
Product description
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Code information (models, lots, serial numbers)
Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
Other devices under the same FDA submission
5 devices cleared under K092684 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Snowden-Pencer 89-6112Steris Corporation · Laparoscope, general & plastic surgery11 reports
- Snowden-Pencer 89-6110Steris Corporation · Laparoscope, general & plastic surgery4 reports
- Snowden-Pencer 89-6109Steris Corporation · Laparoscope, general & plastic surgery2 reports
- Snowden-Pencer 89-6105Steris Corporation · Laparoscope, general & plastic surgery1 report
- Snowden-Pencer 89-6210Steris Corporation · Laparoscope, general & plastic surgery1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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