ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog 60-3000-101-00, Serial # 3005IACJ, 3006JAEP, 3007CADR, 3007EACT, 3007EAKT, 3007GAGR, 3007HABK, 3007KAAR, 3007KAET, 3008CADE, 3008HAHC, 3008LACK, 3009AACN, 3009HABA, 3009LAEF, 3010CABH, 3010DAHG, 3010GAAC, 3010GAAJ, 3011LABL, 3011LABN, 3011LABQ, 3011LACC, 3011LACE, 3011LACF, 3011LACG, 3011LACH, 3011LACJ, 301 1LACK, 3011LACL, 3011LACM, 3011LACN, 3011LACP, 3011LACQ, 3011LACR, 3011LACS, 3011LACT, 3011LACU, 3011LACW, 3011LADA, 3011LADE, 3011LADF, 3011LADG, 3011LADH, 3011LADJ, 3011LADK, 3011LADM, 3011LADP, 3011LADQ, 3011LADR, 3011LADS, 3011LADT, 3011LADU, 3011LADW, 3011LAEA, 3011LAEB, 3011LAEC, 3011LAED, 3011LAEE, 3011LAEF, 3011LAEH, 3012AAAG, 3012AAAK, 3012AAAM, 3012AAAN, 3012AAAP, 3012AAAQ, 3012AAAR, 3012AAAS, 3012AAAT, 3012AAAU, 3012AAAW, 3012AABA, 3012AABB, 3012AABC, 3012AABE, 3012AABG, 3012AABH, 3012AABK, 3012AABL, 3012AABM, 3012AABN, 3012AABQ, 3012AABR, 3012AABS, 3012AABU, 3012AACA, 3012AACB, 3012AACC, 3012AACD, 3012AACE, 3012AACH, 3012AACJ, 3012AACM, 3012AACN, 3012AACP, 3012AACQ, 3012AACR, 3012AACS, 3012AACT, 3012AACW, 3012AADA, 3012AADB, 3012AADC, 3012AADD, 3012AADE, 3012AADF, 3012AADG, 3012BAAA, 3012BAAB, 3012BAAC, 3012BAAD, 3012BAAE, 3012BAAF, 3012BAAG, 3012BAAH, 3012BAAJ, 3012BAAK, 3012BAAL, 3012BAAM, 3012BAAN, 3012BAAP, 3012BAAQ, 3012BAAR, 3012BAAS, 3012BAAT, 3012BAAU, 3012BAAW, 3012BABA, 3012BABB, 3012BABC, 3012BABD, 3012BABE, 3012BABF, 3012BABG, 3012BABH, 3012BABJ, 3012BABK, 3012BABL, 3012BABM, 3012BABN, 3012BABP, 3012BABQ, 3012BABR, 3012BABS, 3012BABT, 3012BABU, 3012BABW, 3012BACE, 3012BACG, 3012BACH, 3012BACJ, 3012BACK, 3012BACL, 3012BACM, 3012BACN, 3012BACP, 3012BACQ, 3012BACR, 3012BACS, 3012BACT, 3012BACU, 3012BACW, 3012BADA, 3012BADB, 3012BADC, 3012BADD, 3012BADG, 3012BADH, 3012BADJ, 3012BADK, 3012BADL, 3012BADN, 3012BADP, 3012BADR, 3012BADS, 3012BADU, 3012BADW, 3012BAEA, 3012BAEB, 3012BAEC, 3012BAEH, 3012BAEJ, 3012BAEL, 3012BAEM, 3012BAEN, 3012BAEQ, 3012BAER French Catalog 60-3000 301-02 Serial # 3012 AAAE German Catalog 60-300060-301-03, Serial # 3012AAAF Spanish Catalog 60-3000-301-11, Serial # 3012AAAB, 3012AAAC, 3012AACG, 3012BACA, 3012BACB, 3012BACC, 3012BACD Dutch 60-3000-301-12, Serial # 3012AAAA, 3012AAAD, 3012EACA
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
Product Codes/Lot Numbers:
Catalog 60-3000-101-00, Serial # 3005IACJ, 3006JAEP, 3007CADR, 3007EACT, 3007EAKT, 3007GAGR, 3007HABK, 3007KAAR, 3007KAET, 3008CADE, 3008HAHC, 3008LACK, 3009AACN, 3009HABA, 3009LAEF, 3010CABH, 3010DAHG, 3010GAAC, 3010GAAJ, 3011LABL, 3011LABN, 3011LABQ, 3011LACC, 3011LACE, 3011LACF, 3011LACG, 3011LACH, 3011LACJ, 301 1LACK, 3011LACL, 3011LACM, 3011LACN, 3011LACP, 3011LACQ, 3011LACR, 3011LACS, 3011LACT, 3011LACU, 3011LACW, 3011LADA, 3011LADE, 3011LADF, 3011LADG, 3011LADH, 3011LADJ, 3011LADK, 3011LADM, 3011LADP, 3011LADQ, 3011LADR, 3011LADS, 3011LADT, 3011LADU, 3011LADW, 3011LAEA, 3011LAEB, 3011LAEC, 3011LAED, 3011LAEE, 3011LAEF, 3011LAEH, 3012AAAG, 3012AAAK, 3012AAAM, 3012AAAN, 3012AAAP, 3012AAAQ, 3012AAAR, 3012AAAS, 3012AAAT, 3012AAAU, 3012AAAW, 3012AABA, 3012AABB, 3012AABC, 3012AABE, 3012AABG, 3012AABH, 3012AABK, 3012AABL, 3012AABM, 3012AABN, 3012AABQ, 3012AABR, 3012AABS, 3012AABU, 3012AACA, 3012AACB, 3012AACC, 3012AACD, 3012AACE, 3012AACH, 3012AACJ, 3012AACM, 3012AACN, 3012AACP, 3012AACQ, 3012AACR, 3012AACS, 3012AACT, 3012AACW, 3012AADA, 3012AADB, 3012AADC, 3012AADD, 3012AADE, 3012AADF, 3012AADG, 3012BAAA, 3012BAAB, 3012BAAC, 3012BAAD, 3012BAAE, 3012BAAF, 3012BAAG, 3012BAAH, 3012BAAJ, 3012BAAK, 3012BAAL, 3012BAAM, 3012BAAN, 3012BAAP, 3012BAAQ, 3012BAAR, 3012BAAS, 3012BAAT, 3012BAAU, 3012BAAW, 3012BABA, 3012BABB, 3012BABC, 3012BABD, 3012BABE, 3012BABF, 3012BABG, 3012BABH, 3012BABJ, 3012BABK, 3012BABL, 3012BABM, 3012BABN, 3012BABP, 3012BABQ, 3012BABR, 3012BABS, 3012BABT, 3012BABU, 3012BABW, 3012BACE, 3012BACG, 3012BACH, 3012BACJ, 3012BACK, 3012BACL, 3012BACM, 3012BACN, 3012BACP, 3012BACQ, 3012BACR, 3012BACS, 3012BACT, 3012BACU, 3012BACW, 3012BADA, 3012BADB, 3012BADC, 3012BADD, 3012BADG, 3012BADH, 3012BADJ, 3012BADK, 3012BADL, 3012BADN, 3012BADP, 3012BADR, 3012BADS, 3012BADU, 3012BADW, 3012BAEA, 3012BAEB, 3012BAEC, 3012BAEH, 3012BAEJ, 3012BAEL, 3012BAEM, 3012BAEN, 3012BAEQ, 3012BAER French Catalog 60-3000 301-02 Serial # 3012 AAAE German Catalog 60-300060-301-03, Serial # 3012AAAF Spanish Catalog 60-3000-301-11, Serial # 3012AAAB, 3012AAAC, 3012AACG, 3012BACA, 3012BACB, 3012BACC, 3012BACD Dutch 60-3000-301-12, Serial # 3012AAAA, 3012AAAD, 3012EACA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0296-2013
Related Recalls
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.