Home / Recalls / Cook Inc. / Z-1780-2019

Z-1780-2019 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
June 19, 2019
Initiation Date
May 2, 2019
Termination Date
August 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
97

Product Description

Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

Reason for Recall

The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.

Distribution Pattern

No distribution in the US. Products were distributed to the following foreign countries: China.

Code Information

lot 8373482

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  • Z-0222-2022 Class II — Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. (October 8, 2021)
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  • Z-0186-2022 Class II — Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-3 (September 28, 2021)
  • Z-0185-2022 Class II — Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 (September 28, 2021)
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  • Z-0604-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5622 (November 24, 2020)
  • Z-0600-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5622 (November 24, 2020)