Reported Jun 10, 2020 · Terminated
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient…
Med Tec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Med Tec Inc · 1401 8th St Se · Orange City, IA · 51041-7463
Is this the product you have?
- Type S Extension For use with Varian, CIVCO
- Prescription Only - Product UsageDevice is intended for patient positioning
- Lot codes and dates
88 of 88 products
Products covered by this recall # Barcodes Product as published 1 00841439104156Part Number: MTCFHNV UDI: 00841439104156 Lot Numbers: M027990 2 M505880 3 M847500 4 M166160 5 M505890 6 M858580 7 M198170 8 M505900 9 M858590 10 M241650 11 M505910 12 M869030 13 M249180 14 M511240 15 M885500 16 M257630 17 M530920 18 M918000 19 M278760 20 M541350 - Amount recalled
- 171 units
Where it was sold
Why it was recalled
Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.
This product could cause temporary or reversible health problems — stop using it.
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