Wilson-Cook Medical Inc. Recall: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order N
Wilson-Cook Medical Inc. Recall: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order N is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Wilson-Cook Medical Inc.; Product: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary
| Recalling firm | Wilson-Cook Medical Inc. |
|---|---|
| Product | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree |
| Reason for recall | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US |
| Recall initiated | 20231103 |
| Recall number | Z-0460-2024 |
| Category | device |
| State | NC |
| Country | United States |
$29/mo
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