—#135099

Product

3/16 in. Curved 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: CAC — Apparatus, Autotransfusion
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K970714
Affected lot / code info: Part Number: 0225-015-000 and lot numbers: 10083012 10349012 11224012 12151012 13092012 13196012 14034012 14246012 10125012 11014012 11257012 12286012 13119012 13248012 14127012 14263012 10162012 11059012 12039012 12341012 13135012 13274012 14165012 10273012 11108012 12075012 13010012 13172012 13326012 14177012 10309012 11160012 12080012 13065012 13191012 14021012 14231012

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 #135099. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.