Synergetics Recalls Sterile Ophthalmic Tubing Sets Due to Seal Failure Risk
Synergetics Inc. is recalling 12 units of sterile ophthalmic tubing sets because faulty seals could fail, potentially compromising sterility.
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 (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synergetics Inc. is recalling 12 units of Standard tubing sets (Catalog No. 17570) due to faulty seals on the outer pouch. The affected products are double-pouched, single-use, sterile ophthalmic devices manufactured in O'Fallon, Missouri.
The recall is being conducted because the faulty seals could result in seal failure. This defect poses a risk to the sterility of the ophthalmic devices. The specific lot number for the recalled items is M269420.
The affected tubing sets were distributed worldwide, including in the United States and 21 other countries. Healthcare providers and consumers should stop using these specific units and contact Synergetics Inc. for instructions on return or replacement.
The recalled product
- Product
- Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
- Manufacturer
- Synergetics Inc
- Affected units
- 12
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)
- Lot number: M269420
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by Synergetics 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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