The Recall Desk
HighFDA (Devices)·Z-0684-2016·Announced 2016-01-27

Abeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise

Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System 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 Class II medical device with a sterility compromise, which poses a risk of harm (infection) in a surgical setting, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System. The product is indicated for use in the retraction of soft tissue away from the operative surface and is available by prescription only.

The recall was initiated after the firm was notified by some customers that certain sealed pouches contain tears. These tears compromise the sterility of the product, which is a critical requirement for surgical instruments used in operative settings.

The affected units were distributed nationwide in the United States and internationally to Austria, Germany, Italy, Japan, Spain, Sweden, and Switzerland. Healthcare facilities and consumers should stop using the affected lots and contact Abeon Medical Corporation for further instructions.

The recalled product

Product
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Manufacturer
Abeon Medical Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2,570

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 M0068201750: Lot # 14112171 Exp Date 2017/11
  • Lot # 14112177 Exp Date 2017/11
  • Lot # 14120576 Exp Date 2017/05
  • Lot # 14120579 Exp Date 2017/11
  • Lot # 14121661 Exp Date 2017/12
  • Lot # 14121862 Exp Date 2017/12
  • Lot # 14121863 Exp Date 2017/12
  • Lot # 15010199 Exp Date 2017/12
  • Lot # 15010200 Exp Date 2017/12
  • Lot # 15011528 Exp Date 2018/01
  • Lot # 15011529 Exp Date 2018/01
  • Lot # 15011530 Exp Date 2018/01
  • Lot # 15011531 Exp Date 2018/01
  • Lot # 15012638 Exp Date 2017/12
  • Lot # 15012640 Exp Date 2017/11
  • Lot # 15013724 Exp Date 2017/11
  • Lot # 15013788 Exp Date 2018/01
  • Lot # 15013789 Exp Date 2018/01
  • Lot # 15013790 Exp Date 2018/01
  • Lot # 15013791 Exp Date 2018/01

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

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 →

Same hazard · sterility compromise

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