Stryker Leibinger Recalls Surgical Drainage Accessories Due to Sterility Labeling Error
Stryker Leibinger is recalling QUINTUBE Monitor Packs and SPG Bulb Drain Systems because non-sterile products were incorrectly labeled as sterile.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a labeling error could lead to the use of non-sterile items in sterile procedures, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling specific lots of QUINTUBE Monitor Packs and SPG Bulb Drain Systems, which are accessories to the TLS Surgical Drainage System. The recall involves 619 units distributed worldwide, including the United States, Australia, Canada, Chile, Spain, South Africa, and Taiwan.
The reason for the recall is an incorrect sterility status on the product labels. Specifically, non-sterile products were labeled as sterile. This labeling error could lead to the use of non-sterile medical devices in sterile surgical procedures, posing a risk of infection or other complications.
Healthcare facilities and distributors should stop using the affected products immediately. Users should check their inventory for the specific part numbers and lot numbers listed in the recall notice. If the products are found, they should be quarantined and returned to Stryker Leibinger for further instructions.
The recalled product
- 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
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Affected units
- 619
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker Leibinger GmbH & Co. KG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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