FDA (Devices) recall action 99062
The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.
Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. Affected kits were distributed nationwide and internationally.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and to Barbados.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products underwent unapproved design changes outside of FDA clearance.
Medline Industries recalls convenience kits containing 10mL polycarbonate colored syringes because design changes were made outside of FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and in Barbados.