FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: 1/4 in. Round Drain with Trocar 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.
- Recall number
- Z-1569-2015
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- 1/4 in. Round Drain with Trocar 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.
- Status
- Terminated
- Initiated
- 2015-03-26
- Posted
- 2015-05-01
- Terminated
- 2015-12-31
- Reason
- Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- Root cause
- Package design/selection
- 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.
- Quantity
- 300 boxes (3,000 each)
- Distribution
- Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
- Lot, serial or model codes
- Part Number: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 1811755
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28