Potential for a weak seal in some units resulting in compromise in sterility.
Reason for recall: Potential for a weak seal in some units resulting in compromise in sterility. Distribution: Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada. Quantity: 82 units Lot/code info: GTIN: 00730822254946; Lot Number: A8041128
00730822254946
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.