openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Product was distributed with incorrect expiration date.
Code information
Finished Product Code: 102008602; Alternate Code: 24013-5; Lot No.: 30143745.
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
device · product 2 of 3
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Product was distributed with incorrect expiration date.
Code information
Finished Product Code: 102005202; Alternate Code: 24014-5; Lot No.: 20065842, 30135996, 30135999, 30137463, 30140309, 30138711, and 30141360.
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
device · product 3 of 3
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Product was distributed with incorrect expiration date.
Code information
Finished Product Code: 102007202; Alternate Code: 240168-5; Lot No.: 30135997, 30137462, 30138710, 30140310, and 30141359.
Distribution pattern
Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
