Home / Recalls / Resource Optimization & Innovation Llc / Z-1677-2017

Z-1677-2017 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

Recall Details

Product Type
Devices
Report Date
April 5, 2017
Initiation Date
January 9, 2017
Termination Date
September 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
670 kits

Product Description

Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis

Reason for Recall

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Distribution Pattern

US Distribution to LA and TX.

Code Information

026385D Exp Date 2017-07-13; 028105D Exp Date 2017-09-14; 029774D Exp Date 2017-12-04; 031980D Exp Date 2018-03-02; 033476D Exp Date 2018-05-10

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  • Z-0169-2018 Class II — Regard Custom Surgical Pack Packs contain surgical instruments and accessorie (September 25, 2017)
  • Z-1548-201 Class II — Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn (January 9, 2017)
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  • Z-1574-2017 Class II — Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU (January 9, 2017)