Terumo Cardiovascular Systems Corp: Cardiovascular Procedure Kit catalog # 76645 & 73806

Is my product affected?

Cardiovascular Procedure Kit catalog # 76645 & 73806

• UPC 00699753507685
• UPC 00699753477728

Check against the official notice below — it lists the full affected range.

What happened

Terumo Cardiovascular Systems Corp. is recalling 64 units of Cardiovascular Procedure Kits due to potential packaging damage that occurred during shipping. The affected kits were distributed nationwide in California and Indiana. Two lot numbers are involved: Lot #Z15957677 (case label GTIN 00699753507685) and Lot #Z16958398 (case label GTIN 00699753477728), both with an expiration date of 230228.

The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

Details from the source

Reason for recall: Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. Distribution: US Nationwide distribution in the states of CA and IN. Quantity: 64 Lot/code info: [Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodi2022-02-03
• NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 50992502022-02-02
• Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Versio2022-02-02
• Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 168132022-02-01
• Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 168142022-02-01

All FDA (Device enforcement) recalls