Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise
Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's 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 medical device where sterility has been compromised, creating a risk of harm during surgical procedures, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames, which are indicated to aid in tissue retraction during surgical procedures. The recall was initiated after the firm was notified by customers that some of the sealed pouches contain tears that compromise the sterility of the product.
The affected products include Part Numbers TLC200 and TLC300, distributed nationwide in the United States and in Austria, Germany, Italy, Japan, Spain, Sweden, and Switzerland. The source text does not specify the number of reported illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected products and contact Abeon Medical Corporation for further instructions or a refund.
The recalled product
- Product
- TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
- Manufacturer
- Abeon Medical Corporation
- Affected units
- 1,035
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 (20)
- Part Number TLC200: Lot # 14121931 Exp Date 2017/12
- Lot # 14121932 Exp Date 2017/12
- Lot # 15010126 Exp Date 2018/01
- Lot # 15013122 Exp Date 2018/01
- Lot # 15013123 Exp Date 2018/01
- Lot # 15024395 Exp Date 2018/02
- Lot # 15024396 Exp Date 2018/02
- Lot # 15031873 Exp Date 2018/03
- Lot # 15032061 Exp Date 2017/12
- Lot # 15034503 Exp Date 2017/10
- Lot # 15040520 Exp Date 2018/02
- Lot # 15041108 Exp Date 2017/12
- Lot # 15044716 Exp Date 2018/04
- Lot # 15050175 Exp Date 2018/01
- Lot # 15051473 Exp Date 2018/05
- Lot # 15051950 Exp Date 2018/04
- Lot # 15054517 Exp Date 2018/05
- Lot # 15062732 Exp Date 2018/04
- Lot # 15070461 Exp Date 2018/02
- Lot # 15070515 Exp Date 2018/02
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abeon Medical Corporation 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Abeon Medical Corporation
See all →- HighAbeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise
FDA (Devices) · 2016-01-27
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