Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A

FDA device recall Z-2011-2012 · posted 2012-07-13 · Terminated

Recall details

Recalling firm

Stingray Surgical Products, LLC

Reason for recall

On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of the FDA.

Action taken

Stingray Surgical Product sent an URGENT Instructions for Use Recall letter dated Mary 23, 2012, to all distributors. The letter identified the product, the problem, and the action to be taken by the client. Distributers were requested to convey the recall to their users along with fowarding copies of the firm's recall notification letter. IFU's will be destroyed or discarded by either user or distributor since returns will not be necessary. Distributors were asked to complete the form at the bottom of the letter and return via e-mail or fax. For questions clients were instructed to call 561-210-7582. For questions regarding this recall call 561-210-7582.

Root cause

Packaging

Status

Terminated

Product code

GEI

Quantity affected

6326

Distribution

Worldwide Distribution - USA (nationwide)

Date initiated

2012-05-23

Date posted

2012-07-13

Date terminated

2014-08-06

Location

Boca Raton, FL

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