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HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), C...

FDA Device Recall #Z-1600-2018 - Class II, December 28, 2017

Recall Summary

Recall Number Z-1600-2018
Classification Class II - Moderate risk
Date Initiated December 28, 2017
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Southwest Technologies Inc
Location Kansas City, MO
Product Type Devices
Quantity 15666 units

Product Description

HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622

Reason for Recall

Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.

Distribution Pattern

worldwide

Lot / Code Information

US distribution: (a) CAP610, Lot Numbers: 020613D 112912B 101312C 040813B 070213F 081513B 100113C 111413B 020314C 032516B 040514B 061014D 072214C 072214C 090914D 090914D 111814B 012115C 032715B 040915D 041615C 043015D 070915D 081815B 090115B 101215C 111315B 122115C 010616B 012116B 022316C 030116B 030515D 031016B 042516C 050616B 052016C 053116C 070816C 072516C 081216B 090216B 091416F 101316D (b) CAP610LV, Lot Numbers: 121912D 041013E 070813B 102413B 121913C 031414D 082014C 091615D OUS distribution: (a) CAP610, Lot Numbers: 011210B 012116B 020110B 020314C 022017B 022316C 030116B 030210B 030711D 032715B 040317C 040514B 040813B 042516C 043015D 050112C 052016C 053116C 060311B 070816C 070915D 072214C 072516C 072817d 081710B 082409B 090115B 091311B 101215C 101312C 101316D 111011B 111413B 111710C 111716L 111814B 112912B 172817d (b) CAP610LV, Lot Numbers: 050610D 091710B 120110B 030711C 040211D 062711C 091311C 031912E 051712C 091112C 102912B 121912D 041013E 070813B 102413B 121913C 031414D 070914C 082014C 110714C 121114C 010815D 041615D 051315C 061615B 091615D 112315B 012116C 021516B 040716B 041516B 052416B 072816B 091616C 101816B 013117C 022117D 030217C 032817D 050317B 071117D (c) CAP613, Lot Numbers: 093015B (d) CAP617, Lot Numbers: 080510D 120211D 092012D 101013B 042215C 102616B (e) CAP619, Lot Numbers: 062309B 051210C 091010C 101910C 112811E (f) CAP619LV, Lot Numbers: 061212C 030513H 100113D 101713C 052114B 110714D 121114D 061515C 091715D 112315C 012116D 021516C 040716C 041516C 013117D 050317C 061217C (g) CAP622, Lot Numbers: 110210C

Other Recalls from Southwest Technologies Inc

Recall # Classification Product Date
Z-2109-2021 Class II Stimulen Collagen Moisturizing Lotion, ST9555B May 28, 2021
Z-0687-2020 Class II Elasto-Gel Absorbent Wound Dressing, Item DR800... Nov 18, 2019
Z-1602-2018 Class II HYPOTHERMIA SLIPPERS Supportive in Cancer, pack... Dec 28, 2017
Z-1601-2018 Class II HYPOTHERMIA MITTS Supportive in Cancer, package... Dec 28, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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