Reported Sep 30, 2015 · Terminated
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301,…
Ecolab Inc.
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: Ecolab Inc · 370 Wabasha St N · Saint Paul, MN · 55102-1323
Is this the product you have?
- Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
- Lot codes and dates
- ORS Fluid Warming Drape, 44" x 44" SKU #
- ORS-100
617 of 617 codes
D112392D112412D112412AD112921D112932D112942D112972D112972AD112982D112992D113002D113002AD113012D113022D113042D113052D113052AD113062D113072D113082D113082AD113092D113112D113122D113122AD113132D113132AD113142D113142AD113152D113152AD113182D113182AD113192D113202D113202AD113252D113252AD113262D113262AD113332D113332AD113342D113342AD113352D113362D113402D113412D113412AD113422D113432D113462D113462AD113472D113482D113532D113542D113552D113552AD120032
- ORS-110
97 of 97 codes
D113472D113482D120022D121312D121352D121432D121672D121812D122162D122222D122432D122522D122882D122902D123262D123272D130153D130243D130253D130263D130333D130673D130723D131423D131493D131563D131623D131703D131793D131843D132043D132173D132341D132451D132521D132591D132731D132801D132841D132941D132981D133121D133291D133321D133381D133471D140201D140341D140381D140501D140531D140711D140791D141051D141191D141271D141471D141531D141621D141641
- ORS-300
535 of 535 codes
D113062D113252D113272D113272AD113282D113342D113352D113362D113362AD113392D113402D113402AD113412D113412AD113462D113472D113472AD113532D113532AD113542D113552D113562D113602D113612D120042D120052D120092D120102D120112D120182D120182AD120202D120262D120282D120392D120412D120442D120452D120462D120482D120522D120532D120542D120582D120582AD120592D120602D120602AD120612D120652D120722D120722AD120732D120732AD120742D120742AD120822D120822AD120832D120832A
- ORS-301
106 of 106 codes
D113482D113492D120602D120702D120822D121182D121222D121282D121362D121432D121602D121852D122162D122222D122362D122522D122552D122932D123472D130022D130173D130233D130313D130393D130433D130493D130583D130653D130743D130813D130863D130933D131003D131063D131123D131213D131363D131423D131473D131553D131623D131703D131793D131853D132043D132103D132173D132331D132451D132521D132591D132661D132801D132841D132941D133051D133151D133191D133291D133401
- ORS-130
108 of 108 codes
D120372D120742D121302D130173D130233D130283D130353D130403D130423D130493D130603D130643D130703D130793D130843D130913D130983D131053D131123D131273D131343D131423D131563D131633D131783D131993D132033D132341D132381D132451D132521D132591D132661D132841D132941D133151D133171D133221D140091D140131D140201D140271D140581D140621D140781D140801D140921D140971D141181D141411D141481D141531D141761D141811D142021D142091D142231D142371D142811D142871
- ORS-320
502 of 502 codes
D113332D113392D113412D113432D113462D113492D120022D120093D120102D120322D120332D120452D120462D120472D120512D120562D120592D120602D120612D120662D120672D120722D120732D120792D120812D120862D120932D120942D120952D121002D121012D121072D121082D121092D121142D121152D121162D121212D121252D121292D121312D121352D121392D121422D121432D121442D121492D121502D121572D121582D121652D121702D121722D121772D121842D121852D121912D121922D121992D122002
- SKU ORS-330
150 of 150 codes
D120382D120522D120872D121282D122202D122782D122822D123342D130233D130293D130353D130423D130493D130593D130653D130713D130803D130843D130913D131003D131063D131123D131283D131353D131423D131473D131563D131783D131853D132033D132103D132173D132341D132381D132521D132711D132801D132841D132941D133151D133171D133231D133291D133431D133501D140201D140281D140341D140421D140621D140721D140781D140971D141051D141111D141181D141281D141341D141411D141631
- Amount recalled
- 5,172,816 units
Where it was sold
Why it was recalled
The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.
This product could cause temporary or reversible health problems — stop using it.
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