FDA Medical Device Recalls (openFDA)
Stryker Leibinger GmbH & Co. KG: QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
- Recall number
- Z-1149-2017
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Product
- QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
- Status
- Terminated
- Initiated
- 2017-01-03
- Posted
- 2017-02-08
- Terminated
- 2017-07-27
- Reason
- An incorrect sterility status on the label, non-sterile products labeled as sterile
- Root cause
- Labeling mix-ups
- Action
- Stryker sent an " URGENT MEDICAL DEVICE RECALL" notifications dated January 3, 2017, to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, instructions for returning affected product, and instructions for responding to the formal recall notification. Please report any adverse events or product quality problems to Stryker CMF Customer Service: 1 (800) 962-6558.
- Quantity
- 619
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
- Lot, serial or model codes
- Part # 6630 QUINTUBE Monitor Pack Lots- M1305008, M1305009, M1305010, M1305011, M1309004, M1309005, M1309006, M1309007, M1309008, M1309009, M1309010, M1607009, M1607010, T1309003 Part # 6649 SPG Bulb Drain System, 4mm Flat w/Center Holes Lot - M1508003
- 510(k) numbers
- ["K833586"]
- PMA numbers
- not on file
- Product code
- GCY
- Firm FEI
- 3002821504
- Firm city
- Freiburg
- Firm state
- not on file
- Firm country
- Germany
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