The Recall Desk
HighFDA (Devices)·Z-2243-2020·Announced 2020-06-10

Med Tec Type S Extension Recalled for Potential Disengagement Risk

Med Tec Inc is recalling Type S Extensions used for patient positioning due to a risk of disengagement during repositioning, which could cause a patient fall.

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 risk-of-harm product (patient fall) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Med Tec Inc is recalling 171 units of the Type S Extension, a prescription-only device intended for patient positioning and used with Varian and CIVCO equipment. The recall is due to a potential for the extension to disengage during patient repositioning.

The risk associated with this disengagement is that a patient could fall if they are not supported by clinical staff. The affected units were distributed worldwide, including nationwide in the United States and in specific countries in Africa, South America, the Middle East, Asia, and Europe.

Healthcare facilities should stop using the affected Type S Extensions and contact Med Tec Inc for instructions on how to return or dispose of the devices. Patients should consult their healthcare providers for guidance on safe positioning alternatives.

The recalled product

Product
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Manufacturer
Med Tec Inc
Affected units
171

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: MTCFHNV UDI: 00841439104156 Lot Numbers: M027990
  • M505880
  • M847500
  • M166160
  • M505890
  • M858580
  • M198170
  • M505900
  • M858590
  • M241650
  • M505910
  • M869030
  • M249180
  • M511240
  • M885500
  • M257630
  • M530920
  • M918000
  • M278760
  • M541350

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically: