FDAClass IIJune 10, 2020

Type S Extension For use with Varian recall

Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.

Why was Type S Extension For use with Varian 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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; M919980; M282330; M553300; M919990; M283380; M553720; M928400; M293670; M553740; M928410; M300750; M596220; M934260; M303010; M596230; M936110; M314410; M616690; M942400; M321880; M616700; M942510; M323560; M649630; M944110; M326580; M649670; M951030; M333420; M649770; M964730; M350700; M715520; M979830; M356130; M715540; M987460; M362290; M743010; M995860; M365740; M767820; M369700; M774760; M371990; M782390; M418080; M796350; M436620; M796360; M439700; M802120; M442410; M805650; M446460; M809050; M448260; M809060; M457870; M820300; M457880; M829290; M462640; M834400; M493710; M844990; M495030; M845000

Product
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Recalling firm
Med Tec Inc
Quantity
171 units
Distribution
Worldwide distribution - US Nationwide distribution including in the states of WI, TX, AZ, FL, NE, TN, MA, FL, GA, IN, OR, PA, IL, LA, NH, MS, MI, OH, MN, VA, IA, CA, NC, SC, AK, UT, WA, MO, MT, KS, and WV. The countries of Africa, Colombia, Saudi Arabia, Costa Rica, South Korea, Hungary, Spain, and Italy.
Recall date
June 10, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls