1 unchanged sentence
Certain legal proceedings pending against us are described in our Annual Report on Form 10-K for the year ended December 31, 2022.
−Removed: Through June 30, 2023, there have been no material developments in any legal proceedings reported in such Annual Report.
+Added: Through September 30, 2023, there have been no material developments in any legal proceedings reported in such Annual Report.
O&M Halyard N95 Mask FDA Release
−Removed: On April 5, 2023 we received a communication from the NIOSH that products from one lot of a model (No.
+Added: On April 5, 2023 we received a communication from the National Institute for Occupational Safety & Health (NIOSH) that products from one lot of a model (No.
46827) of surgical N95 respirator manufactured by O&M Halyard did not pass laboratory tests for fluid resistance and for filtration efficiency, and that products from one lot of another model (No.
46727) did not pass fluid resistance testing, but did pass filtration efficiency testing.
−Removed: At present, our investigation has determined that there are a limited number of lots potentially implicated by the results of the NIOSH particulate filtration testing on model 46827.
−Removed: The vast majority of the products in those lots remain in our possession and under our control, and those lots that had products that did reach the market have passed internal follow-up testing.
−Removed: On April 12, 2023, the FDA recommended that consumers, health care providers, and facilities not use the two models (model numbers 46827 and 46727) of O&M Halyard surgical N95 respirators due to fluid resistance.
−Removed: In addition, the FDA also recommended against using certain of our surgical, procedure and pediatric face masks when fluid resistance is required.
+Added: Our investigation determined that a limited number of lots were potentially implicated by the results of the NIOSH particulate filtration testing on model 46827, and that the vast majority of the products in those lots remained in our possession and under our control.
+Added: Those lots have been segregated for disposal.
+Added: We also determined that a limited quantity of products from one lot did reach the market.
+Added: Although products from that lot passed internal and external follow-up testing for filtration efficiency, we initiated a voluntary recall of the lot on August 9, 2023 out of an abundance of caution.
+Added: O&M Halyard has confirmed to NIOSH that the particle filtration issue was isolated to the identified lots.
+Added: On April 12, 2023, the FDA recommended that consumers, health care providers, and facilities not use the two models (model numbers 46827 and 46727) of O&M Halyard surgical N95 respirators due to concerns about fluid resistance performance.
+Added: In addition, the FDA also recommended against using certain of our surgical, procedure and pediatric face masks
+Added: when fluid resistance is required.
On or about that date, we voluntarily stopped the sale in the U.S.
4 unchanged sentences
These items are included in our Products & Healthcare Services segment.
−Removed: We are thoroughly investigating the matters identified by the FDA and NIOSH and we are performing product retesting as we work closely with government agencies to resolve these matters.
+Added: On September 29, 2023, the FDA updated its previous recommendation to consumers, health care providers and facilities regarding the above-referenced models of O&M Halyard surgical N95 respirators based on extensive testing and performance data provided by O&M Halyard.
+Added: Specifically, the FDA stated that both O&M Halyard respirator models could be used according to the product labeling for respiratory and fluid barrier protection to the wearer (excluding the one lot of products that O&M Halyard voluntarily recalled on August 9, 2023).
+Added: Following the FDA’s update, we published a user notice on our website announcing the resumption of sales and shipments of O&M Halyard surgical N95 respirators, noting that the data provided to the FDA and NIOSH demonstrated that our products provide the levels of particle filtration and fluid resistance for which they are rated.
+Added: NIOSH reviewed and concurred with the facts set forth in our user notice published on September 29, 2023.
+Added: We will continue to work with the FDA and NIOSH following the resolution of this matter to ensure that O&M Halyard products comply with regulatory requirements.
We are unable to reasonably estimate the amount of any possible loss or range of possible losses or predict the ultimate outcome of these matters.
6 unchanged sentences
Certain risk factors that we believe could affect our business and prospects are described in our Annual Report on Form 10-K for the year ended December 31, 2022.
−Removed: Through June 30, 2023, there have been no material changes in the risk factors described in such Annual Report.
+Added: Through September 30, 2023, there have been no material changes in the risk factors described in such Annual Report.
Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.