—#135100

Product

1/8 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:0225-018-000 and lot numbers: 10081012 10272012 11060012 11223012 12074012 13002012 13254012 14167012 10123012 10295012 11104012 11259012 12115012 13022012 13290012 14174012 10138012 10321012 11124012 11284012 12201012 13053012 13318012 14252012 10162012 10334012 11137012 11320012 12250012 13060012 13345012 10182012 10341012 11143012 11361012 12293012 13095012 14031012 10228012 11007012 11188012 12018012 12317012 13138012 14085012 10245012 11043012 11207012 12046012 12340012 13221012 14149012

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 #135100. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.