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FDA Medical Device Recalls (openFDA)

Spinal Specialties, Inc: 22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.

Recall number
Z-0886-05
Recalling firm
Spinal Specialties, Inc
Product
22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.
Status
Terminated
Initiated
2005-04-15
Posted
2005-06-14
Terminated
2005-11-02
Reason
Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
Root cause
Other
Action
The firm initiated the recall via letter on April 15, 2005.
Quantity
542 kits
Distribution
VA, OH, TX, CA, IL, and FL
Lot, serial or model codes
Joliet Pain Center lot numbers: 0804370, 0904191, 0904014, and 0904207;  Suburban Pain Care Center lot number: 0904239;  Medical Practice Managers lot numbers 1104306, 0305143, and 0105001
510(k) numbers
not on file
PMA numbers
not on file
Product code
CAZ
Firm FEI
1000306134
Firm city
San Antonio
Firm state
TX
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

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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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