A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
Check against the official notice below — it lists the full affected range.
Zimmer Surgical Inc. is recalling approximately 8,231 A.T.S. 4000TS Tourniquet Systems used by medical professionals to control blood flow during surgery. The devices are identified by Item No. 60400040400 across multiple lot numbers (62510549, 62510845, 62510927, 62510928, 62525817, and 62525841), with specific serial numbers listed for each lot. The affected devices have been distributed worldwide, including throughout all U.S. states and territories, as well as numerous countries including Australia, Brazil, Canada, China, France, India, and many others.
The reason for the recall involves updates to the on-device label and operator/service manual, as well as a change in the required separation distance between the device and radiofrequency communication equipment, decreased from 3.8 meters to 1.0 meter. The recall record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.
Reason for recall: Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment. Distribution: Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, It Quantity: 8,231 devices total Lot/code info: Item No. 60400040400, Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB, 4013JABC, 4013JABD, 4013JABE, 4013JABF, 4013JABG); Lot No. 62510845 (Serial Numbers: 4013JABH, 4013JABJ, 4013JABK, 4013JABL, 4013JABM, 4013JABN, 4013JABP, 4013JABQ, 4013JABR, 4013JABS, 4013JABT, 4013JABU, 4013JABW, 4013JACA, 4013JACB, 4013JACC, 4013JACD, 4013JACE, 4013JACF, 4013JACG); Lot No. 62510927 (Serial Numbers: 4013JACH, 4013JACJ, 4013JACK, 4013JACL, 4013JACM, 4013JACN, 4013JACP, 4013JACQ, 4013JACR, 4013JACS, 4013JACT, 4013JACU, 4013JACW, 4013JADA, 4013JADB, 4013JADC, 4013JADD, 4013JADE, 4013JADF, 4013JADG); Lot No. 62510928 (Serial Numbers: 4013JADH, 4013JADJ, 4013JADK, 4013JADL, 4013JADM, 4013JADN, 4013JADP, 4013JADQ, 4013JADR, 4013JADS, 4013JADT, 4013JADU, 4013JADW, 4013JAEA, 4013JAEB, 4013JAEC, 4013JAED, 4013JAEE, 4013JAEF, 4013JAEG); Lot No. 62525817 (Serial Numbers: 4013KAAA, 4013KAAB, 4013KAAC, 4013KAAD, 4013KAAE, 4013KAAF, 4013KAAG, 4013KAAH, 4013KAAJ, 4013KAAK, 4013KAAL, 4013KAAM, 4013KAAN, 4013KAAP, 4013KAAQ, 4013KAAR, 4013KAAS, 4013KAAT, 4013KAAU, 4013KAAW); Lot No. 62525841 (Serial Numbers: 4013KABA, 4013KABB, 4013KABC, 4013KABD, 4013KABE, 4013KABF, 4013KABG, 4013KABH, 4013KABJ, 4013KABK, 4013KABL, 4013KABM, 4013KABN, 4013KABP, 4013KABQ, 4013KABR, 4013KABS, 4013KABT, 4013KABU, 4013KABW)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.