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FDA Medical Device Recalls (openFDA)

Benlan, Inc.: Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.

Recall number
Z-1070-2012
Recalling firm
Benlan, Inc.
Product
Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.
Status
Terminated
Initiated
2011-12-12
Posted
2012-02-21
Terminated
2013-03-19
Reason
The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.
Root cause
Process control
Action
The firm initiated their recall of the specified lots of product in November, 2011 by sending a "Customer/Distributor Medical Device Correction" letter to their consignee. The letter requested they examine their inventory, quarantine any affected product and complete a verification and response form to be returned to the firm. Questions were directed to (905) 829-5004 ext 233.
Quantity
143,250
Distribution
Nationwide Distribution, USA - including only the state of Pennsylvania
Lot, serial or model codes
Catalog number 1047080 - lot numbers 076192, 076404, 076904, 077695, 078697, 079540 and 079686.
510(k) numbers
not on file
PMA numbers
not on file
Product code
KYX
Firm FEI
3932
Firm city
Oakville
Firm state
not on file
Firm country
Canada

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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