Recall MonitorHealth Products
SAFE-T-FILL®
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: SAFE-T-FILL®
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information. fieldactions@aspglobal.com
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 07 9502 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 06 0187 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 06 0508 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 07 7120 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 07 7251 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 07 6011 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 07 7250 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 07 9503 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 06 0007 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 06 0402 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 07 7220 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 06 0186 |
| SAFE-T-FILL® | More than 10 numbers, contact manufacturer. | 06 0199 |
Issue
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).