Hospira Recalls Receptal Canisters Due to Suction Failure
Hospira is recalling 1L Receptal Canisters because the canister and liner may not seat properly, preventing the creation of necessary suction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in surgical and airway clearance contexts where failure to create suction poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Hospira Inc. is recalling 1L Receptal Canisters, which are used to isolate suction waste during surgeries or to clear patient airways, throats, or wounds. The recall is due to reports that the vacuum needed to create suction cannot be achieved because the canister and liner do not properly seat.
The affected products are labeled with List Numbers 43449-04-11 and 43449-04-01 for domestic products, and various other list numbers for foreign products. All lot numbers are affected. A total of 3,560 units were distributed from June 2004 to December 2012.
Distribution was worldwide, including nationwide distribution in the United States and specific countries in Canada and EMEA. Healthcare facilities and consumers should stop using these canisters and contact Hospira for instructions on return or replacement.
The recalled product
- Product
- Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.
- Manufacturer
- Hospira Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- *** DOMESTIC PRODUCT *** List Numbers: 43449-04-11 and 43449-04-01
- Lot Numbers: All
- *** FOREIGN PRODUCT *** List Numbers: 0L21297W1
- 0L2129701
- 0L2139701
- 43449001L
- 434490101
- 434490102
- 434490181
- 434490182
- 4344901DX
- 434496101
- 434496161
- 4344961A1
- 434499090
- Lots: All
Distribution
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