FDA Medical Device Recalls (openFDA)
Popper & Sons Inc: 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.
- Recall number
- Z-0881-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-01-02
- Posted
- 2008-02-12
- Terminated
- 2008-05-12
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Lot Number: B/503726-907-2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 2414164
- Firm city
- New Hyde Park
- Firm state
- NY
- Firm country
- not on file
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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