Recall record at a glance
| Official record | Z-2243-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Med Tec Inc. |
| Report date | Jun 10, 2020 |
| Recall initiation date | May 12, 2020 |
| Quantity | 171 units |
| Location | Orange City, IA, United States |
Official product description
Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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