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Trinity Sterile, Inc. Recall 87538

Description: Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

Trinity Sterile, Inc. Recall 87538 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1468-2021
Event ID87538
Event DescriptionMidline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Product TypeDevices
DistributionUS Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
Quantity2970 units
Recall ReasonEvidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Device Classification20210428
Device Code InfoLot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
Center Classification Date20210421
Recall Initiation Date20210223
Recalling FirmTrinity Sterile, Inc.
Initial Notification Letter
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