The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Reason for recall: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. Distribution: Nationwide Quantity: 630 units Lot/code info: a) Reorder Number DYNDA2524, GTIN 40193489361415, Lot # 22HME893 b) Reorder Number DT22705A, GTIN 40653160993224, Lot # 22HMC897 c) Reorder Number IV8635D, GTIN 40653160990261, Lot# 22HMH318 d) Reorder Number MNS12595, GTIN 40653160991015, Lot # 22HMD598
40193489361415, 40653160993224, 40653160990261, 40653160991015
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.