Recall Z-1149-2017 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
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
| Date | Feb 8, 2017 (initiated Jan 3, 2017) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833586 | TLS BULB DRAINAGE SYSTEM Porex Medical, Jan 30, 1984 |