Medical Device Technologies, Inc.: Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 1 - 10cc Syringe L/L; 3 - 20cc Syringe L/L; 1 - Probe Guide; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 3 - 4" x 4" Sponges in stacks of 5; 1 - Towel; 1 - 2" x 3" ADH Dressing; 1 - Specimen Label; 1 - Obturator; 1 - Male Luer Cap; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0387TL***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, customer_service@angio.com, www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

Recall number

Z-0235-2012

Recalling firm

Medical Device Technologies, Inc.

Product

Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 1 - 10cc Syringe L/L; 3 - 20cc Syringe L/L; 1 - Probe Guide; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 3 - 4" x 4" Sponges in stacks of 5; 1 - Towel; 1 - 2" x 3" ADH Dressing; 1 - Specimen Label; 1 - Obturator; 1 - Male Luer Cap; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0387TL***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, customer_service@angio.com, www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

Status

Terminated

Initiated

2010-12-22

Posted

2011-11-18

Terminated

2011-11-30

Reason

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

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

105 boxes

Distribution

Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.

Lot, serial or model codes

Catalog # CB0387TL Lot Number(s): 81991OPX; 83231R08; 90991TRP; 93491YF7; 015221AT; 82661PYN; 90411SIW; 92591WT2; 00121YRP.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OJV

Firm FEI

1036710

Firm city

Gainesville

Firm state

FL

Firm country

not on file

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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