Z-2212-2016Class I

DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404...

Name: Z-2212-2016 DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404...
Creator: Carefusion 2200 Inc
Published: 2016-07-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-07-01 / Terminated / root cause: manufacturing process

FDA source

Carefusion 2200 Inc began a recall of 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... on 2016-07-01. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2212-2016
Classification: Class I
Status: Terminated
Initiated: 2016-07-01
Posted: 2016-07-22
Terminated: 2017-03-29
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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].
Quantity in commerce: 10
Distribution: Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
Product codes and lots: Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2212-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2212-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22

Product code GCJ

K092684Class IILaparoscopic RetractorsCardinal Health, Inc. / cleared 2010-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)