FDA Enforcement Class II Terminated

GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap

Recall: Z-2785-2016 · Reported September 21, 2016

Enforcement

Recall Number
Z-2785-2016
Event ID
74851
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Allergy Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Telephone
Report Date
September 21, 2016
Initiation Date
February 3, 2015
Classification Date
September 12, 2016
Termination Date
March 13, 2017
Address
1005 SW 2nd St, N/A, Oklahoma City, OK, 73109-1006, United States

Description

GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap

Reason

Potential for glass particles within the vials

Code Info

SEV2120414, SEV2120514

Distribution

US Distribution to the state of : NC

Quantity

81,625 vials (3,265 packs)