—#132232

Product

Nerve Block Tray (Nerve Block convenience kit)

FDA product code: OGJ — Nerve Block Tray
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: CMP Kit code: DT13405 Lot numbers: 2014061250 and 2014071750 Expiration date lot 2014061250: 2016-02 Expiration date lot 2014071750: 2016-03

Why it was recalled

According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546-5400 Ext. 1135. For questions regarding this recall call 517-546-5400, ext 1135.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Timeline

Recall initiated: 2014-10-23
Posted by FDA: 2015-01-08
Terminated: 2015-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132232. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.