Recall Z-0762-2018
Steris Corporation · initiated June 15, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 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.
Codes / lots: Model# 884116 Lot# 161229A
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.
FDA-determined cause: Component change control
Action taken
Steris sent an Urgent Voluntary Recall Notice letter dated July 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately inspect on-hand inventory for recalled product. If you have product in your possession, please quarantine it and contact firm to coordinate shipment of replacement product. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873.
Details
- Recall number
- Z-0762-2018
- Initiated
- June 15, 2017
- Terminated
- July 17, 2018
- Product code
- FRG – Wrap, Sterilization
- Quantity
- 8
- Distribution
- US Nationwide Distribution
- Recalling firm
- Steris Corporation, Mentor, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0743-2018 Class II | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0744-2018 Class II | Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0745-2018 Class II | Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0746-2018 Class II | Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0747-2018 Class II | Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0748-2018 Class II | Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0749-2018 Class II | Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0750-2018 Class II | Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0751-2018 Class II | Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0752-2018 Class II | Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0753-2018 Class II | Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0754-2018 Class II | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0755-2018 Class II | Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0756-2018 Class II | Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0757-2018 Class II | Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0758-2018 Class II | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0759-2018 Class II | Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0760-2018 Class II | Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0761-2018 Class II | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0763-2018 Class II | Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0764-2018 Class II | Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0765-2018 Class II | Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0766-2018 Class II | Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0767-2018 Class II | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0768-2018 Class II | Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0769-2018 Class II | Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0770-2018 Class II | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |
| Z-0771-2018 Class II | Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product…On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches… | 06/15/2017Terminated |