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Terminated

Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.

FDA Recall Z-1573-2015 · Posted 2015-05-01

Recall StatusTerminated
Product CodeCAC
Date Initiated2015-03-26
Date Terminated2015-12-31
Product Quantity2,575 boxes (25,750 each)

Reason for Recall

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

Firm Action

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.

Root Cause

Package design/selection

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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