Medical Device
Manufacturing
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Z-2785-2016Class II

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

Allergy Laboratories, Inc. / initiated 2015-02-03 / Terminated / root cause: manufacturing process

Allergy Laboratories, Inc. began a recall of GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap on . FDA classified it as Class II and gives the reason as "Potential for glass particles within the vials". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2785-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Allergy Laboratories, Inc.
Product
GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
Product code
LDH
Reason for recall
Potential for glass particles within the vials
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Allergy Laboratories notified the sole consignee via phone call on February 3, 2015. For further information, please call (405) 235-1451.
Quantity in commerce
81,625 vials (3,265 packs)
Distribution
US Distribution to the state of : NC
Product codes and lots
SEV2120414, SEV2120514

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2785-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2785-2016Class IITerminatedVoluntary: Firm initiated