Applied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach
Applied Medical Technology Inc is recalling 5,334 units of TLC Self Retaining Retractor Systems because a complaint reported an open pouch that breaches sterilization validation.
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 3/5 (High).
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 breach of sterilization validation for a surgical device, which presents a risk of infection or harm. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Applied Medical Technology Inc is recalling 5,334 units of the TLC Self Retaining Retractor System. The product is indicated to aid in tissue retraction during surgical procedures and is available in two part numbers: M0068201750 and M0068201761.
The recall was initiated after the firm received a complaint regarding an open pouch, which breaches the sterilization validation. This defect compromises the sterile integrity of the device.
The affected products were shipped to 28 U.S. states and 9 countries, including Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the United Kingdom. Healthcare facilities and distributors should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
- Manufacturer
- Applied Medical Technology Inc
- Affected units
- 5,334
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 (2)
- Part #: M0068201750
- Part #: M0068201761
Distribution
Part of a larger recall action
This product is one of 4 recalled by Applied Medical Technology 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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