Diamond dusted ILM elevators recalled over voids in pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
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: Scored 3 under the risk-of-harm criterion: the firm states a compromised sterile barrier could lead to infection, and no injuries are reported.
Plain-English summary
This recall by Vortex Surgical Inc. covers the Rumex Disposable Diamond Dusted ILM Elevator, 12-7523.
The record states there may be voids located in the seal of Tyvek pouches associated with the identified catalog numbers and lots, and that a compromised sterile barrier has the potential of bioburden contamination which could lead to infection.
The record lists 14,789 units, of which 8,651 are in the US and 6,138 outside it, with pouch and box UDI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Vortex Surgical's instructions.
The recalled product
- Product
- Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
- Manufacturer
- Vortex Surgical Inc.
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 (1)
- Pouch UDI 5060720920298 Box UDI 5060720920298 Lot 2411033
Distribution
Part of a larger recall action
This product is one of 13 recalled by Vortex Surgical Inc. 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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