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FDA Medical Device Recalls (openFDA)

Gulf South Medical Supply Inc: Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.

Recall number
Z-0295-2013
Recalling firm
Gulf South Medical Supply Inc
Product
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.
Status
Terminated
Initiated
2012-06-20
Posted
2012-11-15
Terminated
2014-08-19
Reason
Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
Root cause
Employee error
Action
The firm, PSS World Medical, sent an "URGENT RECALL NOTICE" dated June 20, 2012 via USPS to all customers that received the product. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, quarantine the affected lot numbers listed in this recall and return the product; If the product was further distributed, to inform their customers of the recall and request they return the affected product directly to them; and contact their Gulf South Customer Care team via telephone at 1-800-347-2456 or email to customercare@gsms.com to request a return goods authorization. If you have any questions, contact the Product Integrity Leader Quality Assurance at 904-380-4501.
Quantity
275 cases and 17 boxes
Distribution
Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
Lot, serial or model codes
Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.
510(k) numbers
["K102152"]
PMA numbers
not on file
Product code
LYZ
Firm FEI
3003119579
Firm city
Jacksonville
Firm state
FL
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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