Reported Jan 18, 2023 · Ongoing
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL,…
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
15 of 15 products
| Model / number | Product as published |
|---|---|
CISION10CS | STERILE BLADE NO. 10 CARBON STEEL |
CISION10CSR | STERILE BLADE NO. 10 CARBON STEEL RIB |
CISION11CS | STERILE BLADE NO. 11 CARBON STEEL |
CISION11SS | STERILE BLADE NO. 11 STAINLESS STEEL |
CISION11CSR | STERILE BLADE NO. 11 CARBON STEEL RIB |
CISION15SS | STERILE BLADE NO. 15 STAINLESS STEEL |
CISION15CS | STERILE BLADE NO. 15 CARBON STEEL |
CISION15CSR | STERILE BLADE NO. 15 CARBON STEEL RIB |
CISION20SS | STERILE BLADE NO. 20 STAINLESS STEEL |
CISION22CS | STERILE BLADE NO. 22 CARBON STEEL |
CISION22SS. | STERILE BLADE NO. 22 STAINLESS STEEL, ***Expansion on 02/06/2023 with the following additional products |
CISION12SS | STERILE BLADE NO. 12 STAINLESS STEEL |
CISION20CS | STERILE BLADE NO. 20 CARBON STEEL |
CISION21CS | STERILE BLADE NO. 21 CARBON STEEL |
CISION21SS. | STERILE BLADE NO. 21 STAINLESS STEEL, Indicated for use in surgical procedures where tissue separation is necessary. |
- Lot codes and dates
15 of 15 products
Products covered by this recall Model / number Barcodes Product as published 2019348909010630193489090103Item Number: CISION10CS, Box UDI/GTIN: 30193489090103, Case UDI/ , Lot Numbers: Y01853, Z00300, Z02246, Z02288, Z02290, Z02416, Z02246, Z02473, Z02290, Z02290, Z02290, Z02290 2019348909011330193489090110Item Number: CISION10CSR, Box UDI/GTIN: 30193489090110, Case UDI/ , Lot Numbers: Z02259, Z02436, Z00381, Z02202, Z02563, Z02261, Z02435 2019348909013730193489090134Item Number: CISION11CS, Box UDI/GTIN: 30193489090134, Case UDI/ , Lot Numbers: Y03382, Z02183, Z02183, Z02183, Z02470, Z02455, Z02183, Z02455, Z02455, Z02455, Z02470 2019348909015130193489090158Item Number: CISION11SS, Box UDI/GTIN: 30193489090158, Case UDI/ , Lot Numbers: Z02339, Z02339, Z02320, Z02364, Z02364, Z02584, Z00402, Z02584, Z02584 2019348909014430193489090141Item Number: CISION11CSR, Box UDI/GTIN: 30193489090141, Case UDI/ , Lot Number: Z01076 2019348909020530193489090202Item Number: CISION15SS, Box UDI/GTIN: 30193489090202, Case UDI/ , Lot Numbers: Y01861, Z00320, Z02233, Z02492, Z02409, Z02409, Z02409, Z02409, Z02409, Z02482, Z00331, Z02233, Z02377, Z02377, Z02377, Z02377, Z02409, Z02409, Z02409, Z02482 2019348909018230193489090189Item Number: CISION15CS, Box UDI/GTIN: 30193489090189, Case UDI/ , Lot Numbers: Y01848, Y03404, Z02188, Z02611, Z02611, Z02188, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611, Z02611 2019348909019930193489090196Item Number: CISION15CSR, Box UDI/GTIN: 30193489090196, Case UDI/ , Lot Numbers: Z02346, Z02346, Z02429, Z02454, Z02429, Z00385 2019348909023630193489090233Item Number: CISION20SS, Box UDI/GTIN: 30193489090233, Case UDI/ , Lot Numbers: Z00343, Z02530 2019348909026730193489090264Item Number: CISION22CS, Box UDI/GTIN: 30193489090264, Case UDI/ , Lot Numbers: Z01064, Z02417, Z02417, Z02198 2019348909028130193489090288Item Number: CISION22SS, Box UDI/GTIN: 30193489090288, Case UDI/ , Lot Numbers: Z02355, Z02403, Z01260, Z02195, Z02355, Z02355. ***Expansion on 02/06/2023 with the following additional products 2019348909017530193489090172Item Number: CISION12SS, Box UDI/GTIN: 30193489090172, Case UDI/ , Lot Number: Z01277 2019348909021230193489090219Item Number: CISION20CS, Box UDI/GTIN: 30193489090219, Case UDI/ , Lot Numbers: Z01206, Z02485, Z02550 2019348909024330193489090240Item Number: CISION21CS, Box UDI/GTIN: 30193489090240, Case UDI/ , Lot Numbers: Z01513, Z02263, Z02452, Z02452, Z02658 2019348909025030193489090257Item Number: CISION21SS, Box UDI/GTIN: 30193489090257, Case UDI/ , Lot Number: Z00312. - Amount recalled
- 76,053 units
Where it was sold
Why it was recalled
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
This product could cause temporary or reversible health problems — stop using it.
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