Home / Recalls / Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. / Z-1484-2017

Z-1484-2017 Class II Terminated

Recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. — Dover, NH

FDA device recall Z-1484-2017 was initiated by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. on February 20, 2017 and is designated Class II. Reason for recall: Incorrect priming volume printed on the device package. The recall status is terminated (terminated April 22, 2019). Affected quantity: 30,700.

Recall Details

Product Type: Devices
Report Date: March 29, 2017
Initiation Date: February 20, 2017
Termination Date: April 22, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30,700

Product Description

AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

Reason for Recall

Incorrect priming volume printed on the device package.

Distribution Pattern

US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV

Code Information

1610092D 1611091D 1612068D 1612074D

Other recalls by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Z-0585-2020 Class II — 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 (September 24, 2019)
Z-0933-2018 Class II — Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Ki (October 3, 2017)
Z-0680-2018 Class II — CVC Tray Pediatrics. Product Code: AMS-9335CP-2. (July 24, 2017)
Z-0681-2018 Class II — 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. (July 24, 2017)
Z-0679-2018 Class II — 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. (July 24, 2017)
Z-0682-2018 Class II — 3-Way Standardbore Stopcock. Product Code: AMS-100. (July 24, 2017)
Z-0678-2018 Class II — Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M (July 24, 2017)
Z-0787-2017 Class II — AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 (November 18, 2016)