SAFE-T-FILL blood collection devices and accessories by Asp Global, identified by catalogue/model numbers 07 9502, 06 0187, 06 0508, 07 7120, 07 7251, 07 6011, 07 7250, 07 9503, 06 0007, 06 0402, 07 7220, 06 0186 and 06 0199, are affected. They were recalled because they can produce falsely elevated blood lead levels when used with Magellan Diagnostics’ LeadCare testing systems (identifier 07 6011), there are production site quality system deficiencies for all identifiers, and some identifiers were distributed without authorization. Contact the manufacturer at fieldactions@aspglobal.com for additional information.
What's being recalled
Companies: Asp Global, 7800 Third Flag Parkway, Austell, Georgia, United States, 30168.
How to identify it
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 07 9502
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 06 0187
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 06 0508
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 07 7120
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 07 7251
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 07 6011
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 07 7250
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 07 9503
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 06 0007
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 06 0402
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 07 7220
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 06 0186
Affected products: SAFE-T-FILL®; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 06 0199
The hazard
The SAFE-T-FILL® blood collection devices and accessories are being recalled due to (i) potential of falsely elevated blood lead levels when used in conjunction with Magellan Diagnostics' leadcare testing systems (identifier 07 6011), (ii) production site quality system deficiencies (all identifiers) and (iii) unauthorized distribution (some identifiers).
What to do
Contact the manufacturer if you require additional information. fieldactions@aspglobal.com
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)