Z-0243-2012

AngiotechGeneral Biopsy Tray 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x...

Name: Z-0243-2012 Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x...
Creator: Medical Device Technologies, Inc.
Published: 2010-12-22
License: https://open.fda.gov/license/

Medical Device Technologies, Inc. / initiated 2010-12-22 / Terminated / root cause: packaging

FDA source

Medical Device Technologies, Inc. began a recall of Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x... on 2010-12-22. The reason FDA records is "Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0243-2012
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-11-18
Terminated: 2011-11-30
Recalling firm: Medical Device Technologies, Inc.
Product: Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - " x 3" Bandage; 2 - Towel; 1 - Fenestrated Drape; 2 - 15mL Specimen Tube; 2 - Specimen Label; 1 - Ruler; 1 - CSR Wrap***Catalog Number: GUTS1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
Product code: OJV Single Use Instrument Tray
Reason for recall: Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Angiotech, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 22, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product. If you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.
Quantity in commerce: 8799 boxes
Distribution: Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
Product codes and lots: Catalog # GUTS1000 Lot Number(s): 81401NHR; 81551NSZ; 81631NZT; 81771OCO; 81911OKS; 82101OWA; 82321PDO; 82381PG9; 82381PGA; 82521PQA; 82521PQB; 82691Q0C; 82731Q2B; 82871QAI; 82881QBS; 82941QEQ; 82961QGR; 83031QLP; 83161QW2; 83171QXI; 83391RAX; 83521RM8; 83531RME; 90051RNB; 90191S0V; 90191S0W; 90271S9J; 90331SCJ; 90471SLP; 90631T1N; 90631T1O; 90701T57; 90761T8G; 90901TJB; 90981TQ6; 91051TTP; 91171U22; 91341UFU; 91391UIB; 91411UKF; 91411UKG; 91531UQW; 91531URF; 91591UVM; 91701V4V; 91891VIV; 92251W8Y; 92261WAX; 92261WAY; 92381WH9; 92521WOL; 92531WPZ; 92531WQ0; 92581WS9; 92711X37; 92711X38; 92791X8E; 93031XNU; 93141XT6; 93291Y3V; 93431YCE; 93481YEG; 93561YIX; 00151YWB; 00191YXZ; 00201YZ3; 00461ZF7; 00611ZPA; 00621ZPT; 00631ZQZ; 009720C7; 010220EO; 010320G0; 010920IB; 012420T1; 012520UN; 013020WS; 013120Y1; 01372117; 01462188; 017921PX; 018321TF; 018721U0; 0263232N; 0264233Q; 02662350; 0267235M; 0267235N; 028723JD; 028723JE; 028823K0; 028823K1; 029323N1.

Product code OJV

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)