# K960248: General Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Physician Industries, Inc.
- Decided: Apr 12, 1996 after 87 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 33 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 22, 2015 · Class II · Z-0193-2016: Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL I
- May 19, 2011 · Not classified · Z-2575-2011: Kits contain protective wipes that may be contaminated with Bacillus cereus.
- May 19, 2011 · Not classified · Z-2576-2011: Kits contain protective wipes that may be contaminated with Bacillus cereus.
- Jul 13, 2009 · Not classified · Z-2094-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2080-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2105-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2079-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2099-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2089-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2103-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2081-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2101-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2100-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2096-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2092-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2097-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2093-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2095-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2086-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2108-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2083-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2088-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2107-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2098-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2102-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2085-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2082-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2104-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2091-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2090-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2087-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Jul 13, 2009 · Not classified · Z-2106-2009: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
- Mar 18, 2008 · Not classified · Z-1635-2008: Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.

Source page: https://510kreport.com/device/K960248
Methodology: https://510kreport.com/methodology