Z-0881-2008

PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE...

Name: Z-0881-2008 PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE...
Creator: Popper & Sons Inc
Published: 2008-01-02
License: https://open.fda.gov/license/

Popper & Sons, Inc. / initiated 2008-01-02 / Terminated / root cause: manufacturing process

FDA source

Popper & Sons Inc began a recall of PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE. Manufactured By: Popper & Sons, Inc. New Hyde Park... on 2008-01-02. The reason FDA records is "Mis-labeling: the product name on the label was erroneously declared as PERFECTUM TOOMEY EVACUATING SYRINGES instead of POPPER INTERCHANGEABLE HYPODERMIC SYRINGES for one lot of the product. Note: the product...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0881-2008
Status: Terminated
Initiated: 2008-01-02
Posted: 2008-02-12
Terminated: 2008-05-12
Recalling firm: Popper & Sons, Inc.
Product: PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE. Manufactured By: Popper & Sons, Inc. New Hyde Park, NY. 11040.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Mis-labeling: the product name on the label was erroneously declared as PERFECTUM TOOMEY EVACUATING SYRINGES instead of POPPER INTERCHANGEABLE HYPODERMIC SYRINGES for one lot of the product. Note: the product information (part number, description, lot number) found in the white box portion of the label is listed correctly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm, Popper & Sons, began contacting its customers by telephone on/about 1/02/08, informing them of the issue. This was followed up with formal recall letters, Urgent Recall, and response forms starting on 1/09/08 via Certified Mail, Return Receipt Requested to the US accounts, and Registered Mail to the two Canadian accounts. The firm has directed the customers to discontinue using or distributing the lot and return any remaining quantity of this lot of syringes. If the lot has been further distributed, the distributors were instructed to immediately contact their accounts, advise them of the recall situation and have them return their outstanding recall stock as indicated above.
Quantity in commerce: Domestic - 259 units; Canada - 13 units
Distribution: Worldwide-USA including the states of NY, NJ, PA, MI, IL, OH, FL, MO, TX, and CA, and country of Canada
Product codes and lots: Lot Number: B/503726-907-2

Product code FMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)