Recall MonitorHealth Products
Surgical Drapes, Packs, Gowns
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Surgical Drapes, Packs, Gowns
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2498 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP3101 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP4119 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8211 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP9001 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2411 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP3009 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP4002 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP4003 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP6006 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8003 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2414UG |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2462 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2492 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP6002 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2410 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2416 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP3003 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP4215 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8002 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8003UG |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8412 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8412UG |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8414 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP3102A |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP4106 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP7001 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP7003 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2412 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2412T |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP3008 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP3103 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8201 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8301 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8304UG |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP9103 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2414 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2418 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2419 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP3109 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8002UG |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8005 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2417 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP2491 |
| Surgical Drape | Lots beginning with 725 or 305 | DYNJP8304A |
| Surgical Pack | Lots beginning with 725 or 305 | DYNJP8401 |
| Surgical Pack | Lots beginning with 725 or 305 | DYNJP1050UG |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2301P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2729 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2003 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2101 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2201S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2302P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2303P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2403 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2705 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2707 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2001S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2003SL |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2101S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2103 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2367P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2401 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2402 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2701 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2802 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2004 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2202 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2203 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2204 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2205S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2002SL |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2366P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2602 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2703 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2728 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2002 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2004S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2102 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2205 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2308P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2362P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2501 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2502 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2702 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2727 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2001 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2002S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2005S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2102S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2201 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2306P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2363P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2709 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2715 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2005 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2202S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2203S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2206S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2307P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2361P |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2704 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2708 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2712 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2801 |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2003S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2009S |
| Surgical Gown | Lots beginning with 725 or 305 | DYNJP2206 |
Issue
Medline identified calibration issues linked to the equipment used to sterilize the recalled products, impacting the sterility assurance level. This creates the potential for a non-sterile device to be placed within the sterile field, or be used within a sterile procedure. This could lead to contamination and/or patient infection. These products are to be destroyed.