Surgical Instrument Service And Savings Recalls Phacofragmentation System Tips
Surgical Instrument Service And Savings, Inc. is recalling specific phacofragmentation system tips because the sterile barrier seal became compromised, allowing the product to fall out of the pouch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a compromised sterile barrier without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling specific lots of phacofragmentation system tips, including the Turbosonics Mini-Flared ABS Tip and Tapered ABS MicroTip. The recall involves 90 units distributed nationwide. The affected products include specific reference numbers and lot numbers: 8065751177 (Lot 123215), 8065750853 (Lots 122590, 123372), 8065750263 (Lot 122309), and 8065740839 (Lot 122309).
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect allows the product to potentially fall out of the pouch, which could compromise the sterility of the device.
Healthcare facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics¿ Tapered ABS¿…
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 90
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 (4)
- 122590
- 123372
- 123215
- 122309.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, 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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