CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches recalled by Steris
Steris is recalling Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per, distributed nationwide in the US. The recall was initiated on 15 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0749-2018
- FDA event ID
- 79100
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2017
- FDA classified
- 27 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 15 Jun 2017 | Recall initiated by company | |
| 27 Feb 2018 | Classified by FDA | +257 days |
| 7 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per recalled?
Yes. Steris recalled Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per on 15 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0749-2018.
Why was it recalled?
On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
Which lots are affected?
Model# 883048 Lot# 161116A
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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