—#135087

Product

3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

FDA product code: GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part Number: 0215-015-200 and lot numbers: 10074012 10280012 11110012 11271012 12066012 12349012 13225012 14022012 10105012 10294012 11138012 11298012 12080012 13016012 13260012 14070012 10118012 10315012 11151012 11346012 12091012 13077012 13268012 14163012 10155012 10319012 11185012 11356012 12181012 13115012 13303012 14169012 10215012 10344012 11189012 12025012 12275012 13120012 13323012 14195012 10242012 11025012 11264012 12053012 12290012 13148012 13346012 14246012 10252012 11033012

Why it was recalled

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Root cause (FDA determination)

Package design/selection

Action the firm took

An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.

Timeline

Recall initiated: 2015-03-26
Posted by FDA: 2015-05-01
Terminated: 2015-12-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.