FDA Device recall Z-1149-2017
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Su…
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Su… by Stryker Leibinger And Kg, citing an incorrect sterility status on the label, non-sterile products labeled as sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1149-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-03 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Leibinger And Kg |
| Distribution | US |
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
Reason
An incorrect sterility status on the label, non-sterile products labeled as sterile
Identifiers
| code_info | Part # 6630 QUINTUBE Monitor Pack Lots- M1305008, M1305009, M1305010, M1305011, M1309004, M1309005, M1309006, M13090…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1149-2017%22
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