Applied Medical Technology Recalls Self-Retaining Retractor Frames Due to Sterilization Breach
Applied Medical Technology is recalling 3,754 units of TLC Self-Retaining Retractor Frames because a complaint reported an open pouch, which breaches sterilization validation.
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 breach of sterilization validation for a surgical device, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Applied Medical Technology Inc is recalling 3,754 units of TLC Self-Retaining Retractor Frames (Part #s TLC200 & TLC300). These single-use, sterile surgical instruments are indicated to aid in tissue retraction during surgical procedures.
The recall was initiated after the firm received a complaint regarding an open pouch, which breaches the sterilization validation for the product. The affected units 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 consumers should stop using the affected retractor frames immediately. Users should contact Applied Medical Technology Inc for further instructions on how to return or dispose of the product.
The recalled product
- Product
- TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
- Manufacturer
- Applied Medical Technology Inc
- Affected units
- 3,754
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)
- Part #: TLC200 & TLC300
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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