Product Safety Recalls

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Stradis Healthcare Recall 90059

Description: Surgical Suture Kit

Stradis Healthcare Recall 90059 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1132-2022
Event ID90059
Event DescriptionSurgical Suture Kit
Product TypeDevices
DistributionUS Distribution to NC.
Quantity7340 units
Recall ReasonThere is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Device Classification20220601
Device Code InfoPart Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
Center Classification Date20220525
Recall Initiation Date20220422
Recalling FirmStradis Healthcare
Initial Notification E-Mail
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